Medtronic recalls
20 official recalls and safety alerts involving Medtronic since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic or the relevant agency.
- 2026-05-06
USMedtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac…
- 2026-01-21
- US
Medtronic Inc recalls Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090…
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
FDA · DeviceMedtronic IncWorldwide - US Nationwide and the countries of Argentina, Australia, Austria,…Official notice → - 2025-12-10
- US
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-07-30
- US
Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application,…
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's…
- 2025-07-23
- US
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure…
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a…
- 2025-06-18
- US
Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac…
FDA · DeviceMedtronic, Inc.International distribution of the country of UK. No US distribution.Official notice → - 2024-09-25
- US
Medtronic Inc. recalls 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031,…
Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
- 2024-07-03
- US
Medtronic Inc. recalls EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
FDA · DeviceMedtronic Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA,…Official notice → - 2024-03-27
- US
Medtronic Inc. recalls Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
There is a potential for sterile package breach.
FDA · DeviceMedtronic Inc.Worldwide distribution - US Nationwide and the countries of Australia, Canary…Official notice → - 2024-01-31
- US
Medtronic Inc. recalls Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the…
- 2024-01-10
- US
Medtronic Inc. recalls Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Seal defects could compromise the ability of the product packaging to maintain sterility.
- 2023-12-20
- US
Medtronic Inc. recalls Medtronic SynchroMed, Model A10
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus,…
- 2023-12-06
- US
Medtronic Inc. recalls ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to…
FDA · DeviceMedtronic Inc.US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic,…Official notice → - 2023-11-29
- US
Medtronic Inc recalls Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external…
FDA · DeviceMedtronic IncWorldwide distribution - US Nationwide and the countries of Algeria, Armenia,…Official notice → - 2022-09-07
- US
Medtronic Inc. recalls EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
- 2022-08-10
- US
Medtronic Inc recalls Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a…
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
- 2022-06-29
- US
Medtronic Inc recalls HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete…
FDA · DeviceMedtronic IncWorldwide Distribution. US nationwide, Austria, Belgium, Finland, France,…Official notice → - 2022-06-15
- US
Medtronic Inc recalls HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post…
FDA · DeviceMedtronic IncWorldwide distribution - US Nationwide DE and TX. There was no…Official notice → - 2022-05-25
- US
Medtronic Inc recalls Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System.…
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
FDA · DeviceMedtronic IncWorldwide Distribution: US (nationwide) and OUS to countries of: Australia,…Official notice → - 2022-04-27
- US
Medtronic Inc recalls Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
There is potential for the capsule bond to break during the procedure.