Medtronic Inc., Cardiac Rhythm and Heart Failure ( Recall: ICD-DR DDMC3D1 EVERA MRI S OUS/
Medtronic Inc., Cardiac Rhythm and Heart Failure ( Recall: ICD-DR DDMC3D1 EVERA MRI S OUS/ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); Product: ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardiove
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
|---|---|
| Product | ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators |
| Reason for recall | There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | US Nationwide - Worldwide Distribution |
| Recall initiated | 20230510 |
| Recall number | Z-1715-2023 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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