BEUDAMED
    FDA Enforcement Class II Ongoing

    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

    Recall: Z-0779-2024 · Reported January 31, 2024

    Enforcement

    Recall Number
    Z-0779-2024
    Event ID
    93663
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 31, 2024
    Initiation Date
    December 7, 2023
    Classification Date
    January 22, 2024
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

    Reason

    During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.

    Code Info

    UDI/DI 00763000178338, Serial Number RSL604096S

    Distribution

    US Nationwide distribution in the state of Florida.

    Quantity

    1 device