BEUDAMED
    FDA Enforcement Class II Terminated

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    Recall: Z-2824-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2824-2018
    Event ID
    80636
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin CRM SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    July 9, 2018
    Classification Date
    August 15, 2018
    Termination Date
    September 6, 2024
    Address
    Cvk, 4, avenue Reaumur, Clamart Cedex, N/A, France

    Description

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    Reason

    Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.

    Code Info

    Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC

    Distribution

    US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS

    Quantity

    16