Z-0550-2022Class I

OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of...

Name: Z-0550-2022 OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of...
Creator: Abiomed, Inc.
Published: 2021-12-14
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2021-12-14 / Terminated / root cause: software

FDA source

Abiomed, Inc. began a recall of 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... on 2021-12-14. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0550-2022
Classification: Class I
Status: Terminated
Initiated: 2021-12-14
Posted: 2022-02-03
Terminated: 2023-02-28
Recalling firm: Abiomed, Inc.
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.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
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.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm began notifying customers by phone starting December 14, 2021. The firm followed up by sending Urgent Medical Device Recall letters to customers on January 20, 2022. The firm is requesting that customers return their devices. The firm does not recommend placing new patients on support. For patients currently on support with an affected system, the firm recommends physicians use their clinical judgement on whether it is appropriate to continue a patient on the OXY-1 System or to transition that patient to the next step in their clinical journey. The letter included instructions on how to return impacted product. If you have questions on returning product, If you have any questions, please contact Diane Welsh from Abiomed s customer service team at (978) 646-1467 or email [email protected]. The firm's Clinical field staff will be available to coordinate boxing and shipping of the OXY-1 system for return to Abiomed. If you have questions regarding this recall, please contact Ralph Barisano directly at (978) 882-8068.
Quantity in commerce: 42 Units
Distribution: US distribution to FL, GA, IN, MD, NC, PA, TX.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0550-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0550-2022	Class I	Terminated	Voluntary: Firm initiated	2022-02-09	2022-02-03

Product code DTZ

K200109Class IIOXY-1 SystemAbiomed, Inc. / cleared 2020-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)