Recall Z-2304-2008 ยท LOZ Artificial Heart
Abiomed, Inc.
Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.
| Date | Sep 20, 2008 (initiated Jun 13, 2008) |
| Status | Terminated |
| Reason | Subassembly incorrectly aligned |
| Root cause | Process control |
| Action | Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced. |
| Quantity | 1 unit |
| Distribution | NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.