Device recall
Z-2568-2025: Automated Impella Controller (AIC) with the below brands and product codes. Used…
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-2568-2025 |
|---|---|
| Recall event | 97440 |
| Product | Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code… |
| Product code | OZD |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 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