Device recall
Z-0441-2024: Automated Impella Controller (AIC), product number 0042-040-US with software…
FDA device recall · Class II · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-0441-2024 |
|---|---|
| Recall event | 93406 |
| Product | Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. |
| Product code | OZD |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 6, 2025 |
| PMA numbers | P140003 |
| FEI number | 1220648 |
At a glance
- None 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