BEUDAMED
    FDA Recall Terminated

    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.

    Recall: Z-1227-2014 · Initiated March 4, 2014

    Recall

    Recall Number
    Z-1227-2014
    Event Number
    67639
    Firm
    Thoratec Corporation
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 4, 2014
    Posted
    March 21, 2014
    Terminated
    August 27, 2015
    Address
    6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

    Description

    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.

    Reason

    Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

    Action

    Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy to [email protected]. For questions call 1-800-528-2577.

    Distribution

    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.

    Quantity

    1737 catalog number 106015; 609 catalog number 106016