Device recall
Z-2680-2026: Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away…
FDA device recall · Class I · Oscor Inc.
Key facts
| Recall number (Z-number) | Z-2680-2026 |
|---|---|
| Recall event | 99102 |
| Product | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. |
| Product code | DYB |
| Recalling firm | Oscor Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K122084 |
| FEI number | 1035166 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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