BEUDAMED
    FDA Enforcement Class II Completed

    Medtronic SynchroMed, Model A10

    Recall: Z-0522-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0522-2024
    Event ID
    93401
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    July 13, 2020
    Classification Date
    December 9, 2023
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    Description

    Medtronic SynchroMed, Model A10

    Reason

    The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

    Code Info

    GTIN 00643169771031, All serial numbers with software version 1.1.300.

    Distribution

    Foreign Distribution

    Quantity

    2543 units