Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support
FDA device recall Z-2382-2010 · posted 2010-09-07 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Pump may separate at the motor housing while device is explanted
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 10 units
- Distribution
- International only: Canada and France
- Date initiated
- 2010-07-05
- Date posted
- 2010-09-07
- Date terminated
- 2010-09-10
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPELLA 5.0 CATHETER FAMILY (K083111) | Abiomed, Inc. | 2009-04-16 |