Browse Device Recalls
336 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 336 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 336 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 3, 2018 | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... | Class II | Medtronic Inc. |
| 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... |
| Aug 7, 2018 | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE,... | There is a potential security vulnerability related to the use of the remote controller accessori... | Class I | Medtronic Inc. |
| Aug 7, 2018 | Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503U... | There is a potential security vulnerability related to the use of the remote controller accessori... | Class I | Medtronic Inc. |
| Jul 4, 2018 | Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. | The application may be closed by the operating system without alerting the user the app is no lon... | Class II | Medtronic Inc. |
| 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... |
| May 16, 2018 | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glu... | CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and di... | Class II | Medtronic Inc. |
| Apr 24, 2018 | Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,... | The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T... | Class II | Medtronic Inc. |
| 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... |
| Nov 3, 2017 | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten... | Stent length on the label may not match the length of the stent itself. | Class II | Medtronic Inc. |
| Oct 10, 2017 | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink... | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so... | Class II | Medtronic Inc. |
| Sep 26, 2017 | 6F Taiga Guiding Catheter | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | Class I | Medtronic Inc |
| Sep 10, 2017 | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Jul 14, 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Med... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 14, 2017 | MyCareLink Smart Patient Monitors. It is intended for use with a compatibl... | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| May 8, 2017 | MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 8, 2017 | MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 8, 2017 | MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 8, 2017 | MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| Apr 12, 2017 | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu... | An unexpected transient mode switch behavior was detected by Medtronic during systems testing tha... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jan 31, 2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... | Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... | Class II | Medtronic Inc. |
| Dec 9, 2016 | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... | During internal testing conducted as part of next generation product development, it was discover... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Nov 16, 2016 | Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusio... | Class II | Medtronic Inc |
| Nov 10, 2016 | ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... | Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire... | Class II | Medtronic Inc |
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.