Company: Medtronic Inc.
Date of Enforcement Report: 6/10/2020
Class II
PRODUCT
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Recall Number: Z-2106-2020
REASON
Customers using the firm’s continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.
RECALLING FIRM/MANUFACTURER
Medtronic Inc. on 5/20/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
23,978
DISTRIBUTION
US Nationwide