OXY-1 System — Class I medical device recall Z-0550-2022

Terminated recall by Abiomed, Inc., reported 2022-02-09, distributed in FL, GA, IN, MD, NC, PA, TX. The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, w

Recall number	`Z-0550-2022`
Product type	Medical device
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Abiomed, Inc., Danvers, MA, United States
Recall initiated	2021-12-14
Classified	2022-02-03
Reported by FDA	2022-02-09
Terminated	2023-02-28
Distributed	FL, GA, IN, MD, NC, PA, TX
Quantity	42 units
UPC / GTIN / UDI-DI	`00860001797909`
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`, `20210795-04`, `20210870-01`, `20210880-01`, `20210890-01`, `20210894-01`, `20210895-01`, `20210896-01`, `20210897-01`
Model numbers	`001-0400-100`, `001-0500-001`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0550-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.