Class I — Abiomed, Inc.
| Recalling firm | ABIOMED, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia. |
| 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. |
| Quantity | 42 Units |
| Distribution | US distribution to FL, GA, IN, MD, NC, PA, TX. |
| Initiated | 2021-12-14 |
| Classified | 2022-02-03 |
| Terminated | 2023-02-28 |
| Recall number | Z-0550-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Abiomed, Inc. (Z-0550-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89328/
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