BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523

    Recall: Z-1591-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1591-2020
    Event ID
    83433
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic MiniMed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    June 27, 2019
    Classification Date
    March 26, 2020
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523

    Reason

    The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

    Code Info

    All software versions 2.4A or lower

    Distribution

    US nationwide distribution including Puerto Rico.

    Quantity

    23,221