BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    Recall: Z-0927-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0927-2021
    Event ID
    86887
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 3, 2021
    Initiation Date
    November 15, 2020
    Classification Date
    January 26, 2021
    Termination Date
    December 23, 2025
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States

    Description

    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

    Reason

    Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

    Code Info

    Serial Numbers: RTP601047S, RTP601055S

    Distribution

    Distribution to US states of GA, PA, NJ, and France

    Quantity

    2 units