Recall Z-1650-2021 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
| Date | Apr 7, 2021 |
| Status | Terminated |
| Reason | The device may contain a manufacturing defect of a missing resistance spot weld (RSW). |
| Root cause | Process control |
| Action | During the week of 07-Apr-2021, Medtronic initiated retrieval activities for 1 device (1 US/0 OUS) for a consignee in possession of a potentially affected, non-implanted device according to Medtronic records. The Consignee was verbally notified that the consigned units was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The representative was made aware that a formal notification to customer regarding these immediate actions would follow once the engineering evaluations were complete. In the United States, beginning 20-Apr-2021, a formal Urgent Medical |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.