BEUDAMED
    FDA Recall Open, Classified

    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

    Recall: Z-1522-2021 · Initiated April 6, 2021

    Recall

    Recall Number
    Z-1522-2021
    Event Number
    87654
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    OSR
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 6, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

    Reason

    There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

    Action

    Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2-day UPS delivery of the consignee letter. Confirmation delivery of the consignee letter will be obtained. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. Consignees were advised that Medtronic representatives can assist in installing the software update on programmers. During device interrogation with an updated programmer at implant or the next regularly scheduled clinic visit, a patients device will automatically receive the updated software. A courtesy notification will be provided to physicians. No confirmation will be required for the courtesy notification.

    Distribution

    Worldwide

    Quantity

    16,311 devices