Device recall
Z-1914-2009: Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a…
FDA device recall · Class II · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-1914-2009 |
|---|---|
| Recall event | 52168 |
| Product | Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is… |
| Product code | DSQ |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2012 |
| PMA numbers | P900023 |
| FEI number | 1220648 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database