Company: Medtronic Inc.
Date of Enforcement Report: 5/15/2019
Class II:
PRODUCT
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Recall Number: Z-1282-2019
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.
RECALLING FIRM/MANUFACTURER
Medtronic Inc. on 7/4/2018. Voluntary: Firm Initiated, recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Approximately 9,328 registered users
DISTRIBUTION
International