Use caution Medical device recall · FDA · Published December 14, 2021

Abiomed OXY-1 System Recall: Power Interruptions Risk Prolonged Hypoxia

Abiomed recalls OXY-1 System Model 001-0500-001 used in cardiopulmonary bypass due to power interruptions causing therapy disruption and potential prolonged hypoxia. Affected units have specific serial numbers and software versions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0550-2022Medical device Abiomed ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575

✎ GovInfoNow plain-language explainer

Abiomed is recalling its OXY-1 System Model 001-0500-001 used during heart-lung bypass surgery because power interruptions can disrupt therapy, potentially causing prolonged low oxygen levels in patients. This recall affects specific units with listed serial numbers and software versions. Read more at govinfonow.com/recall/61433-abiomed-oxy-1-system-recall-power-interruptions-risk-prolonged-hypoxia.

Source Summary by GovInfoNow · govinfonow.com/recall/61433-abiomed-oxy-1-system-recall-power-interruptions-risk-prolonged-hypoxia · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0550-2022

Cite this page

“Abiomed OXY-1 System Recall: Power Interruptions Risk Prolonged Hypoxia.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61433-abiomed-oxy-1-system-recall-power-interruptions-risk-prolonged-hypoxia. Based on FDA recall #Z-0550-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0550-2022%22&limit=1).

Abiomed, Inc. recalled the OXY-1 System on Dec. 14, 2021, according to the FDA. The device may experience power interruptions that disrupt therapy delivered to patients. Owners should contact Abiomed for a replacement console.

How to tell if you have it

Brand: Abiomed
Product: OXY-1 System
Model Number: 001-0500-001
Software Versions: V-1.3.15.0, V-1.4.6.0, 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
Distribution: FL, GA, IN, MD, NC, PA, TX

The hazard

Context

GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since 2019-09-04. Other recent recalls of similar products include Datex-Ohmeda Aisys Anesthesia System Recall (2026-07-30), Datex-Ohmeda Aisys CS2 Anesthesia System Recall (2026-07-30) and Medline Oxygen Masks Recall (2025-11-21).

How to tell if you have this one

Check if your OXY-1 System has the model number 001-0500-001 and serial numbers listed in the recall notice (e.g., 20200231-04, 20200249-01). Also verify the software version is V-1.3.15.0, V-1.4.6.0, or V-1.4.8.0.

Brand
Abiomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Status
Verify your OXY-1 System model number and serial numbers match those listed in the recall notice.
Contact Manufacturer
Reach out to Abiomed directly for guidance on next steps if your unit is affected.

Where it went and when

Where it was distributed

Distributed in 7 states.

FDA distribution: “US distribution to FL, GA, IN, MD, NC, PA, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Georgia, Indiana, Maryland, North Carolina, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

Dec 14, 2021Firm started the recall
Feb 3, 2022FDA classified it Class I
Feb 9, 2022Published in FDA’s Enforcement Report
Feb 28, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61433-abiomed-oxy-1-system-recall-power-interruptions-risk-prolonged-hypoxia">Abiomed OXY-1 System Recall: Power Interruptions Risk Prolonged Hypoxia (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0550-2022 (December 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0550-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.