Mounds View, MN, United States
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls
30 recalls recorded since 2018, most recently on 10 May 2023. 18 are listed as ongoing. Status and classification are as published by the FDA.
Recalls30
Ongoing (FDA)18
Terminated or completed12
Class I (FDA)5
Ongoing Class I Medical devices
- Recall started
- 10 May 2023
- Reason
- There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- Distribution
- US Nationwide - Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1707-2023, Z-1715-2023, Z-1722-2023, Z-1746-2023, Z-1739-2023, Z-1732-2023, Z-1786-2023, Z-1757-2023, Z-1769-2023, Z-1762-2023, Z-1793-2023, Z-1752-2023 and 108 more
- ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
- ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
- ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
- CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
- CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
- CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
- CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
- CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
- and 112 more product lines
Ongoing Class I Medical devices
- Recall started
- 22 June 2022
- Reason
- There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1489-2022, Z-1485-2022, Z-1486-2022, Z-1490-2022, Z-1487-2022, Z-1488-2022
- Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
- Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
- Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
- Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
Ongoing Class II Medical devices
- Recall started
- 20 April 2022
- Reason
- The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Belgium, Denmark, France, Germany, Ireland, Italy,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1206-2022
- The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflecta
Ongoing Class II Medical devices
- Recall started
- 12 April 2022
- Reason
- Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- Distribution
- Distributed nationwide to AK, 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, WY and internationally to Andorra, Australia, Austria, Belgium, Brunei Daru
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1268-2022, Z-1267-2022
- Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, D
- Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D
Terminated Class II Medical devices
- Recall started
- 18 January 2022
- Terminated
- 4 May 2026
- Reason
- Devices may lose functionality due to susceptibility to moisture ingress.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0782-2022
- LINQ II Insertable Cardiac Monitor
Terminated Class II Medical devices
- Recall started
- 19 November 2021
- Terminated
- 16 August 2024
- Reason
- There have been reports of stent migration.
- Distribution
- Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0464-2022
- Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Terminated Class II Medical devices
- Recall started
- 8 November 2021
- Terminated
- 4 May 2026
- Reason
- The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
- Distribution
- US, Canada, Northern Mariana Islands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0390-2022, Z-0391-2022
- Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
- Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Ongoing Class II Medical devices
- Recall started
- 12 October 2021
- Reason
- The processing of collected episode data may fail due to a software error.
- Distribution
- Worldwide distribution - US Nationwide. There was military/government distribution. The countries of Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Irela
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0282-2022
- Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillat
Ongoing Class II Medical devices
- Recall started
- 9 September 2021
- Reason
- Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
- Distribution
- Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0173-2022
- C315-HIS Delivery Catheter
Ongoing Class II Medical devices
- Recall started
- 1 June 2021
- Reason
- Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2102-2021
- Medtronic Reveal LINQ LNQ11 / PA96000
Ongoing Class II Medical devices
- Recall started
- 14 May 2021
- Reason
- Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
- Distribution
- Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2076-2021
- Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Terminated Class II Medical devices
- Recall started
- 7 April 2021
- Terminated
- 23 August 2024
- Reason
- The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
- Distribution
- US Nationwide distribution in the state of North Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1650-2021
- Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate b
Ongoing Class II Medical devices
- Recall started
- 6 April 2021
- Reason
- There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1522-2021, Z-1523-2021
- CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
- CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical device
Ongoing Class II Medical devices
- Recall started
- 6 April 2021
- Reason
- A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1528-2021, Z-1525-2021, Z-1527-2021, Z-1526-2021
- CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Mod
- Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azur
- Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 299
- Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in
Ongoing Class I Medical devices
- Recall started
- 3 February 2021
- Reason
- A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
- Distribution
- Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1306-2021, Z-1305-2021
- Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria fa
- Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD
Terminated Class II Medical devices
- Recall started
- 15 November 2020
- Terminated
- 23 December 2025
- Reason
- Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
- Distribution
- Distribution to US states of GA, PA, NJ, and France
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0928-2021, Z-0927-2021, Z-0926-2021
- Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
- Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
- Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-
Ongoing Class II Medical devices
- Recall started
- 5 November 2020
- Reason
- Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
- Distribution
- US Nationwide distribution in the states of Indiana and CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1480-2022
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Ongoing Class II Medical devices
- Recall started
- 4 June 2020
- Reason
- There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2511-2020, Z-2505-2020, Z-2508-2020, Z-2507-2020, Z-2510-2020, Z-2509-2020, Z-2506-2020, Z-2512-2020, Z-2513-2020
- Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
- CareLink SmartSync Device Manager, Model Number 24970A
- Azure S DR MRI, Model Number W3DR01
- Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
- Azure S SR MRI, Model Number W3SR01
- Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
- Patient Connector, Model Number 24967
- Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 30 January 2020
- Reason
- Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico, Argentina, Brazil, Colombia, Trinidad and Tobago, Venezuela, Dominican Republic, Bahamas, Peru, Bermuda, Barbados, Ecuador, Cayman Islands, Curacao, Guatemala, Honduras, Panama, El Salvador, Costa Rica, Bolivia, Chile, Uruguay, Paraguay,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1524-2020, Z-1525-2020
- Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
- Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Ongoing Class II Medical devices
- Recall started
- 3 October 2019
- Reason
- There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0240-2020, Z-0241-2020, Z-0239-2020
- Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
- Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
- Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Terminated Class II Medical devices
- Recall started
- 6 August 2019
- Terminated
- 26 June 2023
- Reason
- Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2493-2019, Z-2492-2019
- Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
- Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Ongoing Class III Medical devices
- Recall started
- 4 March 2019
- Reason
- The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
- Distribution
- International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1069-2019
- Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during ca
Ongoing Class I Medical devices
- Recall started
- 17 January 2019
- Reason
- A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
- Distribution
- Wordlwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0808-2019, Z-0807-2019, Z-0812-2019, Z-0809-2019, Z-0811-2019, Z-0806-2019, Z-0810-2019
- Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
- Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
- vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
- Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
- Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
- Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number
- Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Terminated Class II Medical devices
- Recall started
- 17 January 2019
- Terminated
- 30 March 2021
- Reason
- There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.
- Distribution
- US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0845-2019
- Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Terminated Class II Medical devices
- Recall started
- 17 January 2019
- Terminated
- 2 February 2021
- Reason
- There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).
- Distribution
- US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0795-2019, Z-0796-2019
- MEDTRONIC CARELINK 2090 programmer
- MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Ongoing Class II Medical devices
- Recall started
- 2 October 2018
- Reason
- Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0407-2019, Z-0406-2019
- Medtronic CareLink Encore 29901 Programmer
- Medtronic CareLink 2090 Programmer
Terminated Class II Medical devices
- Recall started
- 21 June 2018
- Terminated
- 19 August 2020
- Reason
- Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2412-2018, Z-2415-2018, Z-2413-2018, Z-2414-2018
- Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by
- Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rat
- Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rat
- Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by
Terminated Class II Medical devices
- Recall started
- 21 June 2018
- Terminated
- 16 June 2021
- Reason
- Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2416-2018, Z-2421-2018, Z-2419-2018, Z-2417-2018, Z-2418-2018, Z-2420-2018
- Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tac
- Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated trea
- Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to pr
- Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tac
- Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to pr
- Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated trea
Terminated Class II Medical devices
- Recall started
- 6 June 2018
- Terminated
- 13 August 2021
- Reason
- A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR).
- Distribution
- Domestic distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Repu
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2317-2018
- Single Chamber Temporary External Pacemaker, Model 53401
Terminated Class I Medical devices
- Recall started
- 19 December 2017
- Terminated
- 27 August 2021
- Reason
- Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0585-2018, Z-0587-2018, Z-0589-2018, Z-0584-2018, Z-0588-2018, Z-0583-2018, Z-0582-2018, Z-0586-2018
- Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF
- Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D
- Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automat
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (P
- Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPA
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable dev
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Qu
- Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION:
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.