BEUDAMED
    FDA Recall Terminated

    Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    Recall: Z-0004-2007 · Initiated August 25, 2006

    Recall

    Recall Number
    Z-0004-2007
    Event Number
    36186
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 25, 2006
    Posted
    October 3, 2006
    Terminated
    November 27, 2007
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588

    Description

    Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

    Reason

    Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.

    Action

    On 8/26/06, the firm issued letters to all its direct consignees, informing them of the affected product and providing 'IMPORTANT PRODUCT SAFETY BULLETIN'.

    Distribution

    Worldwide distribution-USA including states of AL, CA, CT, FL, IL, IN, KY, LA, MA, ME, MI, MN, NC, NY, OH, PA, TN, TX, VA, WA, and WI., with 19 Foreign consignees Australia, Belgium, Canada*, Czech Republic, France, Germany, Ireland, Netherlands, Portugal, Switzerland, United Kingdom. (*Hospital Royal Victoria, Queen Elizabeth II/Capital Health, St. Paul's Hospital, Vancouver, Canada.)--

    Quantity

    114 devices (57 valves/2 per unit)