CLASS I Device recall · Reported 9 Feb 2022 · FDA Enforcement Report

OXY-1 System recalled by Abiomed

Abiomed is recalling OXY-1 System, distributed in 7 states. The recall was initiated on 14 Dec 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI 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

Quantity recalled42 Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0550-2022
FDA event ID: 89328
Recalling firm: Abiomed, Danvers, MA
Classification: Class I
Status: Terminated
Recall initiated: 14 Dec 2021
FDA classified: 3 Feb 2022
Reported: 9 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

14 Dec 2021	Recall initiated by company
3 Feb 2022	Classified by FDA	+51 days
9 Feb 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

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

Florida Georgia Indiana Maryland North Carolina Pennsylvania Texas

Questions about this recall

Is OXY-1 System recalled?

Yes. Abiomed recalled OXY-1 System on 14 Dec 2021. The recall is Class I and its status is Terminated. Recall number Z-0550-2022.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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