# FDA recall Z-0550-2022

> **Abiomed, Inc.** · Class I · device recall initiated 2021-12-14.

## 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.

## Reason for recall

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.

## Distribution

US distribution to FL, GA, IN, MD, NC, PA, TX.

## Key facts

- **Recall number:** Z-0550-2022
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-14
- **Report date:** 2022-02-09
- **Termination date:** 2023-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2022

## Citation

> AI Analytics. FDA recall Z-0550-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0550-2022. Source: US FDA. Licensed CC0.

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