Browse Device Recalls

198 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 198 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 198 FDA device recalls.

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DateProductReasonClassFirm
Jun 4, 2020 Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Azure S SR MRI, Model Number W3SR01 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Azure S DR MRI, Model Number W3DR01 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 Patient Connector, Model Number 24967 There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 4, 2020 CareLink SmartSync Device Manager, Model Number 24970A There is a rare communication sequence during the first device interrogation with a SmartSync Dev... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020 Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 30, 2020 Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtroni... Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: imp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 6, 2019 Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1V... Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 6, 2019 Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Mar 4, 2019 Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Produ... The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. Class III Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber ... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD):... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: Versa, Dual chamber rate responsive p... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 MEDTRONIC CARELINK 2090 programmer There is an error in how the programmer calculates and displays the remaining longevity value dur... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamb... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 po... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 17, 2019 Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): ... A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 2, 2018 Medtronic CareLink 2090 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual wit... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 2, 2018 Medtronic CareLink Encore 29901 Programmer Vulnerabilities have been identified in the SDN download process that may allow an individual wit... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The imp... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models a... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018 Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 6, 2018 Single Chamber Temporary External Pacemaker, Model 53401 A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.