BEUDAMED
    FDA Enforcement Class I Terminated

    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

    Recall: Z-0659-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0659-2017
    Event ID
    75600
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    SynCardia Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 14, 2016
    Initiation Date
    October 21, 2016
    Classification Date
    December 8, 2016
    Termination Date
    February 21, 2017
    Address
    1992 E Silverlake Rd, N/A, Tucson, AZ, 85713-3865, United States

    Description

    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

    Reason

    The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.

    Code Info

    S/N 5002  UDI (01)00858000003121(21)5002 S/N 5005  UDI (01)00858000003121(21)5005 S/N 5008  UDI (01)00858000003121(21)5008 S/N 5009  UDI (01)00858000003121(21)5009 S/N 5010  UDI (01)00858000003121(21)5010

    Distribution

    US distribution to Virginia and Arizona.

    Quantity

    5