BEUDAMED
    FDA Enforcement Class II Terminated

    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

    Recall: Z-0103-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0103-2019
    Event ID
    80917
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thoratec Switzerland GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    September 5, 2018
    Classification Date
    October 12, 2018
    Termination Date
    April 28, 2021
    Address
    Technoparkstrasse 1, N/A, Zurich, N/A, N/A, Switzerland

    Description

    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

    Reason

    Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

    Code Info

    UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.

    Distribution

    U.S.: OR, AZ, CA, ID, WA, WI, NY, MA, CT, NJ, ME, RI, IL, MI, TN, OH, IN, KY, IA, AL, FL, NC, GA, SC, VA, MD, DC, PA, WV, DE, MN, MT, NE, CO, NM, UT, AR, MO, MC, TX, OK, LA, MS, ND

    Quantity

    1569