Abiomed, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0550-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: December 14, 2021

Date Posted: February 9, 2022

Recall Number: Z-0550-2022

Event ID: 89328

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.

Status: Terminated

Product Quantity: 42 Units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated