Device recall
Z-2601-2026: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected…
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-2601-2026 |
|---|---|
| Recall event | 99002 |
| Product | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. |
| Product code | DYB |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K241708 |
| FEI number | 1220648 |
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