Device recall
Z-1590-2023: Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump…
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-1590-2023 |
|---|---|
| Recall event | 91955 |
| Product | Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US) |
| Product code | OZD |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class I |
| 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