BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-0550-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0550-2022
    Event ID
    89328
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 9, 2022
    Initiation Date
    December 14, 2021
    Classification Date
    February 3, 2022
    Termination Date
    February 28, 2023
    Address
    22 Cherry Hill Dr, N/A, Danvers, MA, 01923-2575, United States

    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.

    Reason

    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.

    Code Info

    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

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

    Quantity

    42 Units