Device recall
Z-0550-2022: OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass…
FDA device recall · Class I · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-0550-2022 |
|---|---|
| Recall event | 89328 |
| Product | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall. |
| Product code | DTZ |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 28, 2023 |
| 510(k) numbers | K200109 |
| 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