BEUDAMED
    FDA Recall Terminated

    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

    Recall: Z-0928-2021 · Initiated November 15, 2020

    Recall

    Recall Number
    Z-0928-2021
    Event Number
    86887
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 15, 2020
    Terminated
    December 23, 2025
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with 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.

    Action

    During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.

    Distribution

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

    Quantity

    2 units