BEUDAMED
    FDA Recall Terminated

    Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.

    Recall: Z-0824-2010 · Initiated December 16, 2009

    Recall

    Recall Number
    Z-0824-2010
    Event Number
    54167
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 16, 2009
    Posted
    March 4, 2010
    Terminated
    July 2, 2014
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923

    Description

    Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.

    Reason

    Console shut down with no audible alarm

    Action

    Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device. For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.

    Distribution

    Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.

    Quantity

    496 units