Danvers, MA, United States
Medtronic Vascular recalls
12 recalls recorded since 2018, most recently on 23 March 2022. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)5
Terminated or completed7
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 23 March 2022
- Reason
- Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minne
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1043-2022, Z-1042-2022
- Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
- Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM0402501
Ongoing Class II Medical devices
- Recall started
- 21 December 2021
- Reason
- Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MOMS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0657-2022
- Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF231
Ongoing Class II Medical devices
- Recall started
- 15 October 2021
- Reason
- Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0291-2022, Z-0290-2022, Z-0292-2022
- Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF282
- Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
- Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESB
Ongoing Class II Medical devices
- Recall started
- 7 June 2021
- Reason
- During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
- Distribution
- U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2135-2021, Z-2136-2021
- Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac
- Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular a
Terminated Class I Medical devices
- Recall started
- 4 May 2021
- Terminated
- 5 January 2023
- Reason
- The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
- Distribution
- US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1860-2021
- Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream pr
Terminated Class II Medical devices
- Recall started
- 28 April 2021
- Terminated
- 5 April 2024
- Reason
- Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
- Distribution
- U.S. Nationwide distribution in the state of GA. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1976-2021
- Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Ongoing Class I Medical devices
- Recall started
- 12 February 2021
- Reason
- Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
- Distribution
- Worldwide distribution. US Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands, Spain, Portugal, France, Israel, Greece, Thailand, Ireland, Colombia, Canada, Hong Kong, Sweden, Belgi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1201-2021
- Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Terminated Class II Medical devices
- Recall started
- 15 January 2021
- Terminated
- 15 June 2023
- Reason
- Sterility may be compromised due to an unsealed pouch
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1248-2021, Z-1247-2021, Z-1246-2021, Z-1245-2021
- Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
- Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
- Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
- Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Terminated Class I Medical devices
- Recall started
- 25 August 2020
- Terminated
- 4 April 2024
- Reason
- Subsequent failure of catheters in the field and failed quality testing
- Distribution
- Worldwide Distribution: USA (nationwide) states of: MA, PA, TN, IN, MI, WA, CA, CO, AZ, NC; and OUS countries of: Algeria, Armenia, Australia, Austria, Barbados, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hungary, India, Ireland, Israel, I
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0087-2021, Z-0089-2021, Z-0088-2021
- Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an
- Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal d
- Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal d
Terminated Class I Medical devices
- Recall started
- 15 March 2019
- Terminated
- 26 April 2024
- Reason
- There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
- Distribution
- Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2624-2019, Z-2661-2019, Z-2564-2019, Z-2730-2019, Z-2690-2019, Z-2623-2019, Z-2751-2019, Z-2611-2019, Z-2681-2019, Z-2701-2019, Z-2641-2019, Z-2629-2019 and 179 more
- SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
- SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
- and 183 more product lines
Terminated Class III Medical devices
- Recall started
- 16 August 2018
- Terminated
- 7 May 2021
- Reason
- Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
- Distribution
- CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3253-2018
- Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Terminated Class II Medical devices
- Recall started
- 13 March 2018
- Terminated
- 7 May 2021
- Reason
- The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
- Distribution
- US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1479-2018
- Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
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.