Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 90429
Description: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 90429 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1480-2022 |
| Event ID | 90429 |
| Event Description | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of Indiana and CA. |
| Quantity | 3 units |
| Recall Reason | Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements. |
| Device Classification | 20220803 |
| Device Code Info | GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S |
| Center Classification Date | 20220728 |
| Recall Initiation Date | 20201105 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Telephone |
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