Recall Z-2382-2010 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Abiomed, Inc.
Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
| Date | Sep 7, 2010 (initiated Jul 5, 2010) |
| Status | Terminated |
| Reason | Pump may separate at the motor housing while device is explanted |
| Root cause | Process control |
| Action | ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used. If you have any questions, contact +49 241 8860-0 or e-mail europe@abiomed.com. |
| Quantity | 10 units |
| Distribution | International only: Canada and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083111 | IMPELLA 5.0 CATHETER FAMILY Abiomed, Inc., Apr 16, 2009 |