Marlborough, MA, United States
Boston Scientific Corporation recalls
123 recalls recorded since 2018, most recently on 10 September 2026. 86 are listed as ongoing. Status and classification are as published by the FDA.
Recalls123
Ongoing (FDA)86
Terminated or completed37
Class I (FDA)19
Ongoing Class II Medical devices
- Recall started
- 10 September 2026
- Reason
- Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0143-2027
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Ongoing Class I Medical devices
- Recall started
- 24 August 2026
- Reason
- Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
- Distribution
- Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3214-2026
- Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041
Ongoing Class II Medical devices
- Recall started
- 6 August 2026
- Reason
- There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3081-2026, Z-3083-2026, Z-3082-2026
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
Ongoing Class II Medical devices
- Recall started
- 22 July 2026
- Reason
- A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AZ, FL, CA, OR, IL, NC, NE, UT, CO, OH, AR, NM, AL, WI, TN, IN, GA, OH, WI, KY, CT, KS, SC, IL, NE, MO, MS, DE, TX, NY, WV, MA, MT, WA, WY, NV, HI, ID, MO, ME, WV, NE, OK, MN, LA, WV, NV, PA, NH, NJ, MI, MO, AK, VA, MS, WY, ME and the
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3188-2026
- Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300
Ongoing Class II Medical devices
- Recall started
- 14 July 2026
- Reason
- Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2961-2026, Z-2962-2026
- OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Ongoing Class I Medical devices
- Recall started
- 9 July 2026
- Reason
- Potential for arterial sheath tip separation or partial tip separation during use.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2978-2026, Z-2977-2026
- Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
- Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Ongoing Class II Medical devices
- Recall started
- 30 June 2026
- Reason
- Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
- Distribution
- US Nationwide distribution. OUS consignee list pending.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2725-2026
- Rapid Refill Continuous Injection System, UPN M00566001
Ongoing Class II Medical devices
- Recall started
- 30 June 2026
- Reason
- Potential for breach in sterile barrier of device packaging.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2840-2026, Z-2839-2026, Z-2838-2026
- Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
- Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer B
- Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Oute
Ongoing Class II Medical devices
- Recall started
- 19 June 2026
- Reason
- Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, LA, MA, MN, NE, NY, OH, OK, OR, SC, SD, TN, TX, UT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2771-2026
- Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Ongoing Class II Medical devices
- Recall started
- 11 June 2026
- Reason
- Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- Distribution
- Global Distribution. US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2755-2026, Z-2757-2026, Z-2754-2026, Z-2756-2026
- FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
- FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
- FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
- FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
Ongoing Class II Medical devices
- Recall started
- 11 June 2026
- Reason
- Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- Distribution
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2753-2026
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Ongoing Class II Medical devices
- Recall started
- 11 June 2026
- Reason
- Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Distribution
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2750-2026, Z-2751-2026, Z-2752-2026
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
- FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Ongoing Class II Medical devices
- Recall started
- 21 May 2026
- Reason
- Potential sterile breach of the pouches in which devices are packaged.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hun
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2629-2026, Z-2628-2026, Z-2630-2026, Z-2626-2026, Z-2633-2026, Z-2635-2026, Z-2636-2026, Z-2632-2026, Z-2637-2026, Z-2627-2026, Z-2634-2026, Z-2631-2026
- CRE Pro Wireguided 12-15mm 240cm
- CRE Pro Wireguided 10-12mm 240cm
- CRE Pro Wireguided 15-18mm 240cm
- CRE Pro Wireguided 6-8mm 240cm
- CRE Wireguided 8-10mm 240cm
- CRE Wireguided 12-15mm 240cm
- CRE Wireguided 15-18mm 240cm
- CRE Wireguided 6-8mm 240cm
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 May 2026
- Reason
- Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2413-2026
- Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic
Completed Class II Medical devices
- Recall started
- 11 May 2026
- Reason
- There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
- Distribution
- US Nationwide distribution in the state of OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2580-2026
- Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Ongoing Class II Medical devices
- Recall started
- 30 March 2026
- Reason
- For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- Distribution
- Worldwide distribution - US Nationwide and the country of Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2048-2026, Z-2049-2026
- LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
- LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
Ongoing Class I Medical devices
- Recall started
- 19 March 2026
- Reason
- Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1771-2026, Z-1770-2026
- Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST C
- Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ES
Ongoing Class II Medical devices
- Recall started
- 10 February 2026
- Reason
- Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1551-2026
- EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Ongoing Class I Medical devices
- Recall started
- 19 December 2025
- Reason
- Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1161-2026, Z-1158-2026, Z-1163-2026, Z-1159-2026, Z-1162-2026, Z-1160-2026
- HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
- *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
- *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Ongoing Class II Medical devices
- Recall started
- 3 December 2025
- Reason
- Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
- Distribution
- US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1042-2026
- Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplast
Ongoing Class II Medical devices
- Recall started
- 11 September 2025
- Reason
- The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0139-2026, Z-0138-2026, Z-0141-2026, Z-0143-2026, Z-0140-2026, Z-0144-2026, Z-0142-2026
- TENACIO Pump without InhibiZone; UPN: 72404420;
- TENACIO Pump with InhibiZone; UPN: 72404429;
- LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
- CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP I
- CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP I
- CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ
Ongoing Class II Medical devices
- Recall started
- 28 August 2025
- Reason
- The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
- Distribution
- US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2618-2025
- Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Ongoing Class I Medical devices
- Recall started
- 20 August 2025
- Reason
- Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0089-2026, Z-0099-2026, Z-0102-2026, Z-0091-2026, Z-0093-2026, Z-0087-2026, Z-0104-2026, Z-0085-2026, Z-0105-2026, Z-0090-2026, Z-0097-2026, Z-0084-2026 and 15 more
- Model Number L211 PROPONENT DR SL MRI Pacemaker
- Model Number S702, ALTRUA 2 DR SL Pacemaker
- Model Number U128, VALITUDE CRT-P EL MRI
- Model Number L231, PROPONENT DR EL MRI Pacemaker
- Model Number L101, ESSENTIO DR SL Pacemaker
- Model Number L209 PROPONENT DR (VDD) SL Pacemaker
- Model Number U226, VISIONIST CRT-P EL
- PROPONENT SR SL (Model L200)
- and 19 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 August 2025
- Reason
- Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
- Distribution
- Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2550-2025, Z-2551-2025
- ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
- Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Ongoing Class II Medical devices
- Recall started
- 5 August 2025
- Reason
- The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2535-2025, Z-2536-2025, Z-2533-2025, Z-2534-2025
- Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
- Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M006225131
- Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral In
- Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Ongoing Class I Medical devices
- Recall started
- 29 July 2025
- Reason
- Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Distribution
- Worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2431-2025, Z-2435-2025, Z-2432-2025, Z-2429-2025, Z-2427-2025, Z-2430-2025, Z-2436-2025, Z-2426-2025, Z-2434-2025, Z-2433-2025, Z-2428-2025
- WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
- WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
- WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
- WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
- WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
- WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
- WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
- WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
- and 3 more product lines
Ongoing Class I Medical devices
- Recall started
- 24 July 2025
- Reason
- Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
- Distribution
- Worldwide Distribution. US nationwide. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2326-2025, Z-2327-2025, Z-2325-2025
- ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
- RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
- ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0
Ongoing Class I Medical devices
- Recall started
- 7 July 2025
- Reason
- Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
- Distribution
- Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2273-2025
- Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT
Ongoing Class II Medical devices
- Recall started
- 25 June 2025
- Reason
- The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2278-2025
- FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Ongoing Class II Medical devices
- Recall started
- 10 June 2025
- Reason
- Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2106-2025, Z-2103-2025, Z-2104-2025, Z-2105-2025
- Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters a
- VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE
- VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
- VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovas
Ongoing Class II Medical devices
- Recall started
- 24 March 2025
- Reason
- Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1687-2025, Z-1689-2025, Z-1686-2025, Z-1688-2025
- IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
- IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
- IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
- IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Ongoing Class II Medical devices
- Recall started
- 20 December 2024
- Reason
- Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1030-2025, Z-1034-2025, Z-1036-2025, Z-1035-2025, Z-1025-2025, Z-1027-2025, Z-1028-2025, Z-1024-2025, Z-1029-2025, Z-1033-2025, Z-1037-2025, Z-1032-2025 and 2 more
- AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
- AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
- AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
- AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
- AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
- and 6 more product lines
Ongoing Class I Medical devices
- Recall started
- 12 December 2024
- Reason
- A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
- Distribution
- US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0823-2025, Z-0826-2025, Z-0822-2025, Z-0824-2025, Z-0827-2025, Z-0825-2025
- PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
- VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
- ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
- ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
- VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
- ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Ongoing Class II Medical devices
- Recall started
- 28 October 2024
- Reason
- Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0530-2025, Z-0531-2025
- AMS Artificial Urinary Sphincter Control Pump
- AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Ongoing Class I Medical devices
- Recall started
- 10 October 2024
- Reason
- Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0298-2025, Z-0300-2025, Z-0302-2025, Z-0301-2025, Z-0303-2025, Z-0299-2025, Z-0297-2025
- Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
- Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
- Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
- Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CR
- Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
- Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Ongoing Class II Medical devices
- Recall started
- 6 September 2024
- Reason
- Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
- Distribution
- Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0226-2025
- Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Ongoing Class II Medical devices
- Recall started
- 5 September 2024
- Reason
- Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.
- Distribution
- US Nationwide distribution in Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0105-2025, Z-0096-2025, Z-0108-2025, Z-0109-2025, Z-0097-2025, Z-0104-2025, Z-0101-2025, Z-0112-2025, Z-0110-2025, Z-0111-2025, Z-0107-2025, Z-0100-2025 and 10 more
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anat
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatom
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical informa
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical informatio
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomica
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical info
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anat
- Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatom
- and 14 more product lines
Ongoing Class II Medical devices
- Recall started
- 1 August 2024
- Reason
- WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Distribution
- Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3271-2024, Z-3287-2024, Z-3284-2024, Z-3279-2024, Z-3277-2024, Z-3280-2024, Z-3282-2024, Z-3265-2024, Z-3270-2024, Z-3293-2024, Z-3268-2024, Z-3283-2024 and 19 more
- WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or
- AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrin
- WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or ext
- WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrins
- WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or ext
- WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsi
- WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or ext
- WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or e
- and 23 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 July 2024
- Reason
- There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- Distribution
- US, Colombia, Philippines, Russia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3151-2024, Z-3149-2024, Z-3150-2024, Z-3148-2024, Z-3147-2024
- VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
- Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
- vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
- Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
- Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Ongoing Class II Medical devices
- Recall started
- 27 June 2024
- Reason
- Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
- Distribution
- Domestic: Nationwide Distribution. International: Pending
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2451-2024, Z-2452-2024
- Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures
- Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
Ongoing Class II Medical devices
- Recall started
- 12 June 2024
- Reason
- Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- Distribution
- Domestic distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2350-2024
- Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Ongoing Class I Medical devices
- Recall started
- 21 March 2024
- Reason
- An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1666-2024, Z-1642-2024, Z-1680-2024, Z-1639-2024, Z-1649-2024, Z-1659-2024, Z-1655-2024, Z-1673-2024, Z-1675-2024, Z-1640-2024, Z-1679-2024, Z-1643-2024 and 36 more
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
- and 40 more product lines
Ongoing Class II Medical devices
- Recall started
- 5 March 2024
- Reason
- Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1396-2024
- OptiCross Coronary Imaging Catheter, REF H749518080120
Ongoing Class II Medical devices
- Recall started
- 20 February 2024
- Reason
- Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- Distribution
- Worldwide distribution - US Nationwide and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1517-2024, Z-1514-2024, Z-1513-2024, Z-1516-2024, Z-1515-2024
- EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M0050919
- EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M0050905
- EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011
- EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
- EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
Ongoing Class I Medical devices
- Recall started
- 20 February 2024
- Reason
- An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1374-2024
- Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Ongoing Class II Medical devices
- Recall started
- 20 February 2024
- Reason
- Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1390-2024
- Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Ongoing Class I Medical devices
- Recall started
- 12 February 2024
- Reason
- Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).
- Distribution
- Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1302-2024
- Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Ongoing Class II Medical devices
- Recall started
- 19 December 2023
- Reason
- Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
- Distribution
- International distribution to the country of Japan only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1153-2024
- EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Ongoing Class II Medical devices
- Recall started
- 30 November 2023
- Reason
- The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
- Distribution
- Distribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin Islands. There was also government/military distribution. Foreign distribution was made to Andorra, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bermuda, Bolivia, Bosnia an
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0673-2024
- Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA
Ongoing Class II Medical devices
- Recall started
- 27 September 2023
- Reason
- Poor image quality due to fluid ingress in the lens.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA VT, WA, WI & WV. The countries of Australia, Belgium, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0396-2024, Z-0397-2024
- EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
- EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Ongoing Class II Medical devices
- Recall started
- 27 July 2023
- Reason
- Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
- Distribution
- US Nationwide distribution in the state of Indiana.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0024-2024, Z-0014-2024, Z-0015-2024, Z-0012-2024, Z-0009-2024, Z-0016-2024, Z-0021-2024, Z-0011-2024, Z-0022-2024, Z-0019-2024, Z-0023-2024, Z-0013-2024 and 4 more
- Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
- Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
- Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
- Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
- Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
- Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
- Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
- Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
- and 8 more product lines
Ongoing Class II Medical devices
- Recall started
- 11 July 2023
- Reason
- There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2441-2023, Z-2442-2023
- EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
- EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Ongoing Class II Medical devices
- Recall started
- 25 May 2023
- Reason
- Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2230-2023, Z-2229-2023, Z-2232-2023, Z-2228-2023, Z-2231-2023, Z-2233-2023, Z-2234-2023
- Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
- Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
- Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
- Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
- Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
- Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
- Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Ongoing Class II Medical devices
- Recall started
- 5 April 2023
- Reason
- The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1592-2023, Z-1593-2023
- WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
- WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Ongoing Class II Medical devices
- Recall started
- 2 February 2023
- Reason
- Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Iraq, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexic
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1397-2023
- Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M0
Ongoing Class II Medical devices
- Recall started
- 2 February 2023
- Reason
- Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..
- Distribution
- US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1216-2023
- LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Ongoing Class II Medical devices
- Recall started
- 13 October 2022
- Reason
- Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
- Distribution
- Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0149-2023
- EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Ongoing Class II Medical devices
- Recall started
- 10 October 2022
- Reason
- ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention
- Distribution
- Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Iraq Ireland Isr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0224-2023, Z-0225-2023, Z-0226-2023
- ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision w
- ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior t
- ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a
Ongoing Class II Medical devices
- Recall started
- 30 September 2022
- Reason
- There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
- Distribution
- Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0151-2023, Z-0152-2023
- EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
- EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Ongoing Class II Medical devices
- Recall started
- 9 August 2022
- Reason
- The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
- Distribution
- International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1582-2022
- Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Ongoing Class II Medical devices
- Recall started
- 7 July 2022
- Reason
- There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1671-2022, Z-1670-2022, Z-1669-2022
- The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse ge
- The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse ge
- The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communicat
Ongoing Class III Medical devices
- Recall started
- 31 May 2022
- Reason
- Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.
- Distribution
- Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1392-2022
- GreenLight HPSEA Laser Fibers, UPN 0010-2092
Ongoing Class II Medical devices
- Recall started
- 25 May 2022
- Reason
- Product may be mislabeled.
- Distribution
- US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1492-2022, Z-1491-2022
- EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouch
- EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouch
Ongoing Class II Medical devices
- Recall started
- 8 March 2022
- Reason
- Pouch seals may be open, compromising sterility.
- Distribution
- Distribution in the US and territories, Japan, and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0915-2022, Z-0916-2022
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Ongoing Class II Medical devices
- Recall started
- 3 March 2022
- Reason
- Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1080-2022, Z-1079-2022, Z-1081-2022, Z-1082-2022
- EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various proce
- EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various proce
- EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedu
- EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various proced
Ongoing Class II Medical devices
- Recall started
- 24 February 2022
- Reason
- Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1002-2022, Z-1003-2022
- SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to
- SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior r
Ongoing Class II Medical devices
- Recall started
- 22 December 2021
- Reason
- Sterility of device is compromised due to a sterile barrier breach
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0760-2022, Z-0773-2022, Z-0763-2022, Z-0753-2022, Z-0770-2022, Z-0769-2022, Z-0765-2022, Z-0755-2022, Z-0758-2022, Z-0777-2022, Z-0754-2022, Z-0767-2022 and 19 more
- HYDRATOME RX 44-20MM/450CM Material Number: M00583060
- JAGTOME RX 44-20-260-035 Material Number: M00573040
- HYDRATOME RX 49-20MM/260CM Material Number: M00583000
- DREAMTOME 44-30MM/260CM Material Number: M00584050
- JAGTOME RX 39-30-260-025 Material Number: M00573100
- JAGTOME RX 39-20-450-025 Material Number: M00573090
- JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
- DREAMTOME 49-20MM/260CM Material Number: M00584000
- and 23 more product lines
Terminated Class II Medical devices
- Recall started
- 8 November 2021
- Terminated
- 2 May 2023
- Reason
- Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0381-2022
- Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Ongoing Class II Medical devices
- Recall started
- 21 October 2021
- Reason
- Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0323-2022, Z-0327-2022, Z-0326-2022, Z-0321-2022, Z-0320-2022, Z-0324-2022, Z-0325-2022, Z-0322-2022
- HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
- HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
- HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
- HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
- HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
- HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
- HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
- HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Ongoing Class II Medical devices
- Recall started
- 23 July 2021
- Reason
- Potential for leaks and loosening at the patient catheter connection
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2327-2021, Z-2328-2021
- TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Ongoing Class II Medical devices
- Recall started
- 3 June 2021
- Reason
- Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2000-2021, Z-2002-2021, Z-2001-2021, Z-1998-2021, Z-2003-2021, Z-1999-2021
- Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
- VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
- Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
- Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
- VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
- Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Ongoing Class I Medical devices
- Recall started
- 3 June 2021
- Reason
- The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2020-2021, Z-2019-2021, Z-2016-2021, Z-2015-2021, Z-2018-2021, Z-2017-2021
- INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
- INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
- INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
- ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
- INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
- VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
Terminated Class II Medical devices
- Recall started
- 21 April 2021
- Terminated
- 7 August 2023
- Reason
- One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, DE, HI, IL, KS, KY, MA, MD, NC, NJ, NV, NY, OH, OK, PA,PR, TX, VA,WA,WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1621-2021
- ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or prox
Ongoing Class II Medical devices
- Recall started
- 15 April 2021
- Reason
- Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1491-2021, Z-1490-2021
- UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.
- Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Ongoing Class I Medical devices
- Recall started
- 12 April 2021
- Reason
- The firm has received reports of stent migration after implantation
- Distribution
- Worldwide - US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1591-2021, Z-1592-2021
- VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
- VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Terminated Class II Medical devices
- Recall started
- 26 March 2021
- Terminated
- 4 March 2024
- Reason
- An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
- Distribution
- Worldwide distribution. US distribution to AR, AZ, CO, FL, GA, IA, MI, MO, NE, OR, PA, TN, TX, and UT. Belgium, France, Portugal
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1433-2021
- The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resist
Terminated Class III Medical devices
- Recall started
- 16 March 2021
- Terminated
- 2 May 2022
- Reason
- May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
- Distribution
- US Nationwide distribution in the states of CA, FL, NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1492-2021
- EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Terminated Class II Medical devices
- Recall started
- 5 March 2021
- Terminated
- 5 January 2023
- Reason
- The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
- Distribution
- Distributed nationwide to AL, AR, AZ, CO, FL, GA, IA, IL, KY, LA, MI, MN, MO, MS, NC, ND, NV, NY, OK, OH, PR, SC, TN, VA, WA, WI and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1429-2021, Z-1430-2021
- MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
- MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
Ongoing Class II Medical devices
- Recall started
- 19 January 2021
- Reason
- Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1168-2021, Z-1170-2021, Z-1169-2021
- Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320;
- Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (
- Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M
Terminated Class II Medical devices
- Recall started
- 15 December 2020
- Terminated
- 14 August 2023
- Reason
- Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
- Distribution
- US Nationwide distribution including in the states of Tulsa, OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0870-2021
- ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Ongoing Class II Medical devices
- Recall started
- 2 December 2020
- Reason
- Accelerated battery depletion may result in a need for device replacement earlier than expected.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0935-2021, Z-0936-2021
- EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
- EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Terminated Class I Medical devices
- Recall started
- 2 December 2020
- Terminated
- 23 June 2022
- Reason
- Electrical overstress may lead to device malfunction.
- Distribution
- Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0950-2021, Z-0951-2021
- EMBLEM S-ICD Model A209
- EMBLEM MRI S-ICD Model A219
Terminated Class II Medical devices
- Recall started
- 1 December 2020
- Terminated
- 14 July 2023
- Reason
- The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
- Distribution
- US Nationwide distribution - Foreign: TBD.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0778-2021, Z-0775-2021, Z-0777-2021, Z-0773-2021, Z-0776-2021, Z-0774-2021
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or
- AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-of
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or
- AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-of
- Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or
- AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-of
Completed Class II Medical devices
- Recall started
- 18 November 2020
- Reason
- Complaint trend regarding needle shaft gas leaks.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0676-2021, Z-0660-2021, Z-0663-2021, Z-0689-2021, Z-0661-2021, Z-0665-2021, Z-0675-2021, Z-0681-2021, Z-0664-2021, Z-0674-2021, Z-0672-2021, Z-0657-2021 and 25 more
- IceSeed" 1.5 Cryoablation Needle
- IcePearl" 2.1 CX 90¿ Cryoablation Needle
- IceRod" 1.5 CX 90¿ Cryoablation Needle¿
- Five IceSphere" Prostate Cryoablation Kit
- IcePearl" 2.1 CX Cryoablation Needle
- IceRod" 1.5 i-Thaw" Cryoablation Needle
- IceSeed" 1.5 90¿ Cryoablation Needle
- IceSeed" 1.5 MRI Cryoablation Needle
- and 29 more product lines
Terminated Class I Medical devices
- Recall started
- 17 November 2020
- Terminated
- 24 January 2022
- Reason
- Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
- Distribution
- Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0728-2021, Z-0729-2021, Z-0730-2021, Z-0736-2021, Z-0735-2021, Z-0734-2021
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
- Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Ongoing Class II Medical devices
- Recall started
- 16 November 2020
- Reason
- Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
- Distribution
- Distribution US nationwide and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0758-2021, Z-0757-2021
- Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
- Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Terminated Class I Medical devices
- Recall started
- 13 November 2020
- Terminated
- 23 July 2024
- Reason
- There is potential for fractures which results in the inability to delivery therapy.
- Distribution
- Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0879-2021
- EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Ongoing Class II Medical devices
- Recall started
- 3 November 2020
- Reason
- This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.
- Distribution
- No US distribution. Foreign distribution to Latin America and EU.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0637-2021
- EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the phys
Ongoing Class II Medical devices
- Recall started
- 24 September 2020
- Reason
- The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Argentina Ecuador Lebanon Saudi Arabia Australia Estonia Malaysia Serbia Austria Finland Malta Singapore Bahrain France Mexico Slovenia Belarus Germany Netherlands South Africa Belgium Great Britain New Zealand South Ko
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0427-2021
- AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Terminated Class II Medical devices
- Recall started
- 22 September 2020
- Terminated
- 4 September 2024
- Reason
- There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
- Distribution
- Distributed in US - AR, FL, IL, and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0319-2021
- Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Terminated Class II Medical devices
- Recall started
- 22 September 2020
- Terminated
- 22 September 2021
- Reason
- Incorrectly installed base.
- Distribution
- US Nationwide distribution including in the state of Rochester, MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0287-2021
- Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the proced
Ongoing Class II Medical devices
- Recall started
- 16 September 2020
- Reason
- RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
- Distribution
- Worldwide distribution - US Nationwide and International distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0286-2021
- Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at
Terminated Class II Medical devices
- Recall started
- 24 August 2020
- Terminated
- 5 April 2024
- Reason
- Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
- Distribution
- US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0181-2021
- Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 258567
Terminated Class II Medical devices
- Recall started
- 7 August 2020
- Terminated
- 23 December 2020
- Reason
- Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2958-2020
- WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of
Ongoing Class II Medical devices
- Recall started
- 6 July 2020
- Reason
- BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
- Distribution
- World wide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2765-2020, Z-2761-2020, Z-2763-2020, Z-2762-2020, Z-2764-2020, Z-2759-2020, Z-2760-2020
- Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diame
- Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diame
- Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diame
- Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diame
- Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sh
- Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diame
- Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diame
Terminated Class II Medical devices
- Recall started
- 4 June 2020
- Terminated
- 23 September 2024
- Reason
- The needle surface deteriorated due to unexpected electrolysis during procedure.
- Distribution
- Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2679-2020, Z-2680-2020, Z-2676-2020, Z-2675-2020, Z-2683-2020, Z-2678-2020, Z-2674-2020, Z-2682-2020, Z-2681-2020, Z-2677-2020
- Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during su
- Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 30 March 2020
- Terminated
- 5 April 2023
- Reason
- To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
- Distribution
- Worldwide distribution - US Nationwide and Global distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1798-2020
- MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Ongoing Class II Medical devices
- Recall started
- 9 March 2020
- Reason
- An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- Distribution
- Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1734-2020, Z-1740-2020, Z-1732-2020, Z-1730-2020, Z-1738-2020, Z-1731-2020, Z-1736-2020, Z-1737-2020, Z-1739-2020, Z-1729-2020, Z-1733-2020, Z-1735-2020
- Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
- Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
- Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
- Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
- Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
- Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
- Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
- Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 12 February 2020
- Terminated
- 14 April 2023
- Reason
- Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
- Distribution
- US Nationwide distribution in the states of NC, TN, and MO.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1511-2020, Z-1512-2020
- Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific
- Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) a
Ongoing Class I Medical devices
- Recall started
- 11 February 2020
- Reason
- Potential for tip detachment of Imager II 5F Angiographic Catheters
- Distribution
- Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1555-2020
- Imager II 5F Angiographic Catheters, 5 units per package.
Terminated Class II Medical devices
- Recall started
- 17 December 2019
- Terminated
- 4 June 2020
- Reason
- A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
- Distribution
- US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2045-2020
- AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 25 June 2020
- Reason
- During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0667-2020, Z-0668-2020
- Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency gene
- Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency gene
Terminated Class II Medical devices
- Recall started
- 8 November 2019
- Terminated
- 24 March 2021
- Reason
- Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
- Distribution
- Worldwide distribution - US Nationwide distribution and country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0717-2020
- AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H
Terminated Class II Medical devices
- Recall started
- 24 October 2019
- Terminated
- 20 March 2023
- Reason
- Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
- Distribution
- Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0579-2020, Z-0578-2020, Z-0580-2020, Z-0577-2020
- NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350,
- Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
- Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a
- Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE
Terminated Class II Medical devices
- Recall started
- 21 October 2019
- Terminated
- 20 December 2023
- Reason
- Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- Distribution
- Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0557-2020, Z-0550-2020, Z-0554-2020, Z-0558-2020, Z-0555-2020, Z-0559-2020, Z-0549-2020, Z-0548-2020, Z-0560-2020, Z-0556-2020, Z-0551-2020, Z-0552-2020 and 1 more
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
- Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
- and 5 more product lines
Completed Class II Medical devices
- Recall started
- 18 September 2019
- Reason
- Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.
- Distribution
- OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1804-2020
- iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Ongoing Class II Medical devices
- Recall started
- 21 August 2019
- Reason
- Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
- Distribution
- Nationwide distribution to Alabama, Arizona, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Or
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2543-2019, Z-2542-2019
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Terminated Class II Medical devices
- Recall started
- 19 July 2019
- Terminated
- 23 April 2020
- Reason
- Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
- Distribution
- MN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2442-2019
- AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Terminated Class II Medical devices
- Recall started
- 8 April 2019
- Terminated
- 10 May 2023
- Reason
- Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
- Distribution
- Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates and Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1396-2019, Z-1399-2019, Z-1391-2019, Z-1395-2019, Z-1397-2019, Z-1392-2019, Z-1393-2019, Z-1398-2019, Z-1394-2019
- AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedur
- AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical proced
- AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedur
- AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as
- AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as
- AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures
- AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical pr
- AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedure
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 26 December 2018
- Terminated
- 17 April 2020
- Reason
- The sterile barrier may contain packaging seal defects.
- Distribution
- The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1013-2019, Z-1012-2019
- Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
- Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Terminated Class II Medical devices
- Recall started
- 19 December 2018
- Terminated
- 9 June 2020
- Reason
- A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
- Distribution
- Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0852-2019
- Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transl
Ongoing Class III Medical devices
- Recall started
- 28 November 2018
- Reason
- Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
- Distribution
- Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0701-2019, Z-0699-2019, Z-0700-2019
- IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrop
- Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electroph
- IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrop
Terminated Class II Medical devices
- Recall started
- 1 November 2018
- Terminated
- 4 November 2019
- Reason
- Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
- Distribution
- US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0474-2019
- The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ven
Terminated Class II Medical devices
- Recall started
- 10 September 2018
- Terminated
- 4 November 2019
- Reason
- Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3258-2018, Z-3256-2018, Z-3257-2018, Z-3255-2018, Z-3259-2018
- VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
- PROPONENT Pacemaker
- ACCOLADE Pacemaker
- ESSENTIO Pacemaker
- VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Terminated Class II Medical devices
- Recall started
- 10 September 2018
- Terminated
- 22 September 2021
- Reason
- There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
- Distribution
- Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3260-2018
- Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable
Ongoing Class II Medical devices
- Recall started
- 20 June 2018
- Reason
- Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
- Distribution
- U.S.: PA, IL, NY, CA, SC, AR, SD, AZ, KY, FL, TX, MA, MI, OH, LA, VA, NC, WA, DE, IN, TN, NJ, CT, AL, ME, GA, NH, MN, MD, DC, OK, HI, WI, CO, MO, IA, GU, NE, OR, ID, UT, RI, KS, NV, MS, WV Foreign (OUS): Canada, Albania, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0202-2019
- Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
Terminated Class II Medical devices
- Recall started
- 12 February 2018
- Terminated
- 10 April 2020
- Reason
- Potential for Capio sutures to break and /or detach.
- Distribution
- Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1617-2018, Z-1619-2018, Z-1624-2018, Z-1618-2018, Z-1625-2018, Z-1626-2018, Z-1622-2018, Z-1623-2018, Z-1620-2018, Z-1616-2018, Z-1621-2018
- Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
- Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative s
- PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
- PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 20 December 2017
- Terminated
- 13 December 2019
- Reason
- Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
- Distribution
- Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakist
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1133-2018
- SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Terminated Class II Medical devices
- Recall started
- 12 December 2017
- Terminated
- 24 October 2019
- Reason
- Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
- Distribution
- Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Arge
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1104-2018, Z-1103-2018, Z-1100-2018, Z-1099-2018, Z-1102-2018, Z-1101-2018
- Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnosti
- Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the f
- Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following:
- Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while mai
- Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the f
- Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following:
Terminated Class II Medical devices
- Recall started
- 11 December 2017
- Terminated
- 4 November 2019
- Reason
- Potential polymer material degradation.
- Distribution
- Worldwide - US Nationwide Distribution - AL, FL, IL, IN, KY, MA, MI, MN, MS, NC, NV, NY, OH, OR, TN, TX, UT, WA and the country CANADA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2735-2018
- Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner
Ongoing Class II Medical devices
- Recall started
- 7 December 2017
- Reason
- Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
- Distribution
- AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0373-2018, Z-0355-2018, Z-0354-2018, Z-0365-2018, Z-0368-2018, Z-0364-2018, Z-0359-2018, Z-0374-2018, Z-0360-2018, Z-0375-2018, Z-0358-2018, Z-0357-2018 and 12 more
- PROPONENT SR Pacemaker
- ACCOLADE DR Pacemaker
- ACCOLADE SR Pacemaker
- VISIONIST CRT-P Pacemaker
- ESSENTIO DR Pacemaker
- ALTRUA 2 EL DR Pacemaker
- ACCOLADE MRI EL DR Pacemaker
- PROPONENT DR Pacemaker
- and 16 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 November 2017
- Reason
- Stent possibly unable to be fully released from the delivery system.
- Distribution
- Worldwide Distribution - US Nationwide Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed internationally to Canad
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0685-2018, Z-0686-2018
- Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the tre
- Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the tr
Terminated Class II Medical devices
- Recall started
- 22 September 2017
- Terminated
- 14 August 2018
- Reason
- Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
- Distribution
- International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0898-2018, Z-0897-2018
- Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
- Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.