BEUDAMED
    FDA Recall Terminated

    BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000

    Recall: Z-1222-03 · Initiated August 19, 2003

    Recall

    Recall Number
    Z-1222-03
    Event Number
    27071
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 19, 2003
    Posted
    September 11, 2003
    Terminated
    October 15, 2003
    Address
    22 Cherry Hill Drive, Danvers, MA, 01923

    Description

    BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000

    Reason

    Bi-Ventricular support system may switch to battery when primary voltage (AC) is available

    Action

    Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.

    Distribution

    Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX

    Quantity

    36