BEUDAMED
    FDA Recall Terminated

    Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588

    Recall: Z-0212-2008 · Initiated October 19, 2007

    Recall

    Recall Number
    Z-0212-2008
    Event Number
    45486
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 19, 2007
    Posted
    November 21, 2007
    Terminated
    May 26, 2009
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588

    Description

    Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588

    Reason

    Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).

    Action

    An initial communication was sent to all affected IVAD customers on October 19, 2007, in the form of an "Urgent: Medical Device Correction" notice informing them of the problem. The correction notice requests that its customers/physicians take the following actions: 1) Contact all ongoing patients with IVADs placed in the paracorporeal position to evaluate the percutaneous line adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles. 2) Remind implanting surgeons and support staff of proper percutaneous line management and provide the patient with a copy of the recall information provided. Complete and sign an Acknowledgement form and fax it to Thoratec Regulatory Affairs. This is a User Level Recall. The firm also issued a November 7, 2007, Press Statement- Urgent Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device.

    Distribution

    Worldwide: USA including states of AL,AR,AZ,CA,CO, FL,GA, IA,IL, IN,KS,KY,LA, MA, MD, ME,MI, MN, MO,NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI and to the following countries: Austria, Canada, France, Netherlands, Singapore, Switzerland, and The United Kingdom

    Quantity

    766