Device recall
Z-2115-2023: Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-2115-2023 |
|---|---|
| Recall event | 92321 |
| Product | Impella CP intravascular micro axial blood pump, Product Number 0048-0032 |
| 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