BEUDAMED
    FDA Recall 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 · Initiated December 14, 2021

    Recall

    Recall Number
    Z-0550-2022
    Event Number
    89328
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    December 14, 2021
    Posted
    February 3, 2022
    Terminated
    February 28, 2023
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    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.

    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.

    Distribution

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

    Quantity

    42 Units