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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) FDA Recalls
146 recalls on file across devices, 128 of them Class I and 141 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter DefibrillatorsClass IMay 10, 2023There is a rare potential for reduced- or no-energy output d |
| Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICClass IJun 22, 2022There is the potential for reduced shock energy (~79% of pro |
| Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, MClass IJun 22, 2022There is the potential for reduced shock energy (~79% of pro |
| Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, ModeClass IJun 22, 2022There is the potential for reduced shock energy (~79% of pro |
| Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, ModClass IJun 22, 2022There is the potential for reduced shock energy (~79% of pro |
| Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Class IJun 22, 2022There is the potential for reduced shock energy (~79% of pro |
| Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Class IJun 22, 2022There is the potential for reduced shock energy (~79% of pro |
| The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,Class IIApr 20, 2022The firm's internal processes identified that certain lots m |
| Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3Class IIApr 12, 2022Telemetry error that may occur with Medtronic Cobalt and Cro |
| Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVClass IIApr 12, 2022Telemetry error that may occur with Medtronic Cobalt and Cro |
| LINQ II Insertable Cardiac MonitorClass IIJan 18, 2022Devices may lose functionality due to susceptibility to mois |
| Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.Class IINov 19, 2021There have been reports of stent migration. |
| Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72Class IINov 8, 2021The back of some Medical Device Identification Cards provide |
| Medical Device Identification Cards associated with Astra XT DR Implantable pulse generatorClass IINov 8, 2021The back of some Medical Device Identification Cards provide |
| Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and CrClass IIOct 12, 2021The processing of collected episode data may fail due to a s |
| C315-HIS Delivery CatheterClass IISep 9, 2021Medtronic is recalling three lots of unused C315HIS Delivery |
| Medtronic Reveal LINQ LNQ11 / PA96000Class IIJun 1, 2021Reveal LINQ with TruRhythm ICMs, that undergo a partial elec |
| Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx OnlyClass IIMay 14, 2021Device fail to detect Brady episodes, Pause (Asystole) episo |
| Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - ProClass IIApr 7, 2021The device may contain a manufacturing defect of a missing r |
| Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bClass IIApr 6, 2021A longevity estimation error may occur in the early years o |
| Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provClass IIApr 6, 2021A longevity estimation error may occur in the early years o |
| CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-PClass IIApr 6, 2021A longevity estimation error may occur in the early years o |
| CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05Class IIApr 6, 2021There is a SmartSync software issue that results in an overe |
| CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).Class IIApr 6, 2021There is a SmartSync software issue that results in an overe |
| Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P deviClass IIApr 6, 2021A longevity estimation error may occur in the early years o |
| Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CClass IFeb 3, 2021A small percentage of implanted cardiac devices, from a well |
| Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DClass IFeb 3, 2021A small percentage of implanted cardiac devices, from a well |