Device recall
Z-2382-2010: Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0…
FDA device recall · Class II · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-2382-2010 |
|---|---|
| Recall event | 56315 |
| Product | 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 |
| Product code | KFM |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2010 |
| 510(k) numbers | K083111 |
| FEI number | 1220648 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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