BEUDAMED
    FDA Recall Terminated

    Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.

    Recall: Z-1914-2009 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-1914-2009
    Event Number
    52168
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    May 8, 2009
    Posted
    September 1, 2009
    Terminated
    January 26, 2012
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923

    Description

    Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.

    Reason

    The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition.

    Action

    Abiomed notified customers via an Urgent - Voluntary Medical Device Field Removal Notice on May 8, 2009 advising users that the Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. The letter stated that customers may continue to support patients with the AB Portable Driver during the process since the failure has not occurred during patient support. An Abiomed Field Service Engineer will contact customers and arrange for a temporary exchange for the affected driver with a corrected driver. The firm recommends that customers switch the patient to hand pump support and switch patient to backup driver until they can confirm that the Driver(s) has been corrected by an Abiomed Field Service. Questions are to be directed to Michael O'Hara at 978-646-1543 or a Field Service at 800-554-8666.

    Distribution

    Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.

    Quantity

    18 units