BEUDAMED
    FDA Recall Open, Classified

    Medtronic CareLink Encore 29901 Programmer

    Recall: Z-0407-2019 · Initiated October 2, 2018

    Recall

    Recall Number
    Z-0407-2019
    Event Number
    81300
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    OSR
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 2, 2018
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic CareLink Encore 29901 Programmer

    Reason

    Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

    Action

    The firm began disseminating the Field Corrective Action notices by hand delivery on 10/02/2018 and followed with the posting of Medtronic Security Bulletin and the Urgent Medical Device Correction customer letter online on 10/11/2018. The notice explained vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download and beginning October 11th, 2018, Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method.

    Distribution

    Worldwide

    Quantity

    4072 units