BEUDAMED
    FDA Enforcement Class I 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 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1227-2014
    Event ID
    67639
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thoratec Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    April 2, 2014
    Initiation Date
    March 4, 2014
    Classification Date
    March 21, 2014
    Termination Date
    August 27, 2015
    Address
    6035 Stoneridge Dr, N/A, Pleasanton, CA, 94588-3270, United States

    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.

    Code Info

    Catalog number 106015 (NAm) 106016 - EU all serial numbers

    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