Browse Device Recalls
207 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 207 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 207 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2023 | CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardi... | 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 DDME3D4 MIRRO MRI, Model Number DDME3D4; 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 DDMD3D4 PRIMO MRI, Model Number DDMD3D4; 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-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; 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 DVME3D4 MIRRO MRI, Model Number DVME3D4; 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 | CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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 | CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; 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 | CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; 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 | ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; 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 COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter... | 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 DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; 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 | ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; 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 | CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; 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 DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; 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 DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; 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 DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; 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 | ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; 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-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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 | CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; 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 DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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 COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; 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 | CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter... | 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 DR MRI IS1 DF1, Model Number DDPC3D1; 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 | CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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 | ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; 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 | CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardi... | 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 DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardi... | 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 DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter... | 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 DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; 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-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; 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 DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; 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 COBALT HF MRI IS1 DF4, Model Number DTPB2D4; 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 | CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; 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 | CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; 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 | ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; 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 DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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 DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable ... | 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 DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardi... | 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 DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; 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 | CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverte... | 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 DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; 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 CROME DR MRI IS1 DF4, Model Number DDPC3D4; 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-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter... | 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 QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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 | ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; 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 DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; 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 DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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... |
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.