Device recall
Z-1030-2026: Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
FDA device recall · Class II · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-1030-2026 |
|---|---|
| Recall event | 98086 |
| Product | Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU. |
| Product code | OZD |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P140003 |
| 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