BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1282-2019 · Initiated July 4, 2018

    Recall

    Recall Number
    Z-1282-2019
    Event Number
    81656
    Firm
    Medtronic Inc.
    FEI Number
    3003166194
    Product Code
    MDS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 4, 2018
    Terminated
    June 6, 2022
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    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.

    Action

    A Field Corrective Action was initiated outside of the U.S. by the recalling firm's global regions on 7/4/2018.

    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