BEUDAMED
    FDA Recall Terminated

    MEDTRONIC CARELINK 2090 programmer

    Recall: Z-0795-2019 · Initiated January 17, 2019

    Recall

    Recall Number
    Z-0795-2019
    Event Number
    81949
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    OSR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 17, 2019
    Terminated
    February 2, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    MEDTRONIC CARELINK 2090 programmer

    Reason

    There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

    Action

    In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand delivered a courtesy FCA Notification Letter to consignees who, according to Medtronic records, have programmers that are eligible for Micra software updates. Field Representatives will update the identified programmers using a provided USB. Notification will also be hand delivered to Micra Implanting or Follow-up physicians for awareness of the issue.

    Distribution

    US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic

    Quantity

    33007 units