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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2023 | ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardio... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardiover... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Ca... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Def... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter D... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Car... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardiove... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardiovert... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardiover... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter De... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Car... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable C... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardiov... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable C... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 10, 2023 | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Card... | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 22, 2022 | Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 20, 2022 | The C304-HIS device features a guide wire to access the vein, a valve to redu... | The firm's internal processes identified that certain lots may have an improperly sealed barrier ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 12, 2022 | Cobalt Models loaded with CareLink SmartSync Device Manager application softw... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 12, 2022 | Crome Models loaded with CareLink SmartSync Device Manager application softwa... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 18, 2022 | LINQ II Insertable Cardiac Monitor | Devices may lose functionality due to susceptibility to moisture ingress. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 19, 2021 | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-... | There have been reports of stent migration. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Medical Device Identification Cards associated with Astra XT DR Implantable p... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 8, 2021 | Medical Device Identification Cards associated with Sprint Quattro Lead, Prod... | The back of some Medical Device Identification Cards provided to patients were printed with an er... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 12, 2021 | Medtronic CareLink SmartSync Device Manager application software (D00U005) us... | The processing of collected episode data may fail due to a software error. | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Sep 9, 2021 | C315-HIS Delivery Catheter | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inabi... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 1, 2021 | Medtronic Reveal LINQ LNQ11 / PA96000 | Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 14, 2021 | Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO ... | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through PO... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 7, 2021 | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Card... | The device may contain a manufacturing defect of a missing resistance spot weld (RSW). | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Programmers - Product Usage: used to treat arrhythmias related to bradycardia... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... | A longevity estimation error may occur in the early years of device life when a unipolar pacing ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 6, 2021 | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl... | There is a SmartSync software issue that results in an overestimation in the displayed longevity ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditi... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable ca... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 15, 2020 | Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual cha... | Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Nov 5, 2020 | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... | Manufacturing error that may have resulted in a cathode component being out of specification. Al... | Class II | 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.