BEUDAMED
    FDA Enforcement Class II Ongoing

    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

    Recall: Z-0776-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0776-2023
    Event ID
    91260
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic MiniMed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2023
    Initiation Date
    November 21, 2022
    Classification Date
    December 31, 2022
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

    Reason

    An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

    Code Info

    App Version 1.3.0

    Distribution

    OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom

    Quantity

    3235