Device recall
Z-0824-2010: Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000…
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-0824-2010 |
|---|---|
| Recall event | 54167 |
| Product | Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction. |
| Product code | DSQ |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 2, 2014 |
| 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