Device recall
Z-2304-2008: Abiomed: Abiocor Implantable Heart Replacement Kit System Catalog Number…
FDA device recall · Class II · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-2304-2008 |
|---|---|
| Recall event | 48724 |
| Product | Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart. |
| Product code | LOZ |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2008 |
| FEI number | 1220648 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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