Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328
Description: ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1722-2023 |
| Event ID | 92328 |
| Event Description | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 3 units |
| Recall Reason | 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. |
| Device Classification | 20230628 |
| Device Code Info | GTIN 00763000615611. Lot Serial Numbers: RSL602260S, RSL602263S, RSL602265S |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
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