BEUDAMED
    FDA Enforcement Class II Terminated

    Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

    Recall: Z-1282-2019 · Reported May 15, 2019

    Enforcement

    Recall Number
    Z-1282-2019
    Event ID
    81656
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2019
    Initiation Date
    July 4, 2018
    Classification Date
    May 3, 2019
    Termination Date
    June 6, 2022
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

    Reason

    The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.

    Code Info

    UDI - (01)00643169693142(10)

    Distribution

    Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.

    Quantity

    Approximately 9,328 registered users