Recall Z-1480-2022 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
| Date | Jul 28, 2022 (initiated Nov 5, 2020) |
| Status | Open, Classified |
| Reason | Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements. |
| Root cause | Process control |
| Action | On 05-Nov-2020, Medtronic initiated retrieval activities via verbal communication to consignees who were in possession of unused, affected devices according to Medtronic records. Consignees were advised to quarantine all affected devices within their possession. In the United States, a written communication was mailed to two (2) identified consignees on 24-Nov-2020, directing the return of all unused, affected devices. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of Indiana and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.