BEUDAMED
    FDA Recall Terminated

    Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    Recall: Z-0412-2007 · Initiated September 24, 2004

    Recall

    Recall Number
    Z-0412-2007
    Event Number
    36154
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2004
    Posted
    February 10, 2007
    Terminated
    April 18, 2008
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588

    Description

    Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    Reason

    The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.

    Action

    The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches.

    Distribution

    Worldwide

    Quantity

    331