Device recall
Z-2686-2026: ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039…
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-2686-2026 |
|---|---|
| Recall event | 98893 |
| Product | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories |
| Product code | DYB |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K192769, K201116 |
| FEI number | 1220648 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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