---
title: "OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. ... — FDA record Z-0550-2022 | Is It on Recall"
description: "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 su"
url: https://isitonrecall.com/recall/fda-device-z-0550-2022-oxy-1-system-model-number-001-0500-001-used-during-cardiopulmonary-bypass-oxy-1-system-consists-of-c/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump D... — FDA record Z-0550-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class I
- **Recalling firm**: Abiomed, Inc.
- **Quantity**: 42 Units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0550-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0550-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI 00860001797909 Software Version Number V-1.3.15.0, V-1.4.6.0 and V.1.4.8.0 Serial Numbers 20200231-04 20200249-01 20200249-05 20200309-02 20200339-01 20200339-03 20200352-01 20200442-01 20200442-02 20200442-05 20210768-01 20210795-02 20210870-01 20210880-01 20210890-01 20210894-01 20210895-01 20210896-01 20210897-01 20210795-04 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Feb 9, 2022
- **Recall initiation date**: Dec 14, 2021
- **Center classification date**: Feb 3, 2022
- **Termination date**: Feb 28, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0550-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abiomed, Inc. records](https://isitonrecall.com/brand/abiomed-inc/)