Recall Z-1485-2022 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
| Date | Aug 9, 2022 (initiated Jun 22, 2022) |
| Status | Open, Classified |
| Reason | There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). |
| Root cause | Device Design |
| Action | Beginning 22-JUN-2022 communications to all affected consignees began. In the United States notifications are sent via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification. Consignees are asked to quarantine the subset of unused identified |
| Quantity | 6884 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.