Recall Z-0928-2021 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
| Date | Nov 15, 2020 |
| Status | Terminated |
| Reason | Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| Root cause | Process control |
| Action | During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers. |
| Quantity | 2 units |
| Distribution | Distribution to US states of GA, PA, NJ, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.