BEUDAMED
    FDA Recall Terminated

    Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

    Recall: Z-0508-2020 · Initiated October 11, 2019

    Recall

    Recall Number
    Z-0508-2020
    Event Number
    84037
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 11, 2019
    Posted
    December 3, 2019
    Terminated
    September 15, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

    Reason

    There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.

    Action

    Medtronic Representatives began communicating to consignees starting 10/09/2019. Beginning 10/11/2019, Medtronic sent letters via mail. The letters explained the issue and requested the return of any unused units.

    Distribution

    US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)

    Quantity

    10820 units