Company: Medtronic Inc.
Date of Enforcement Report: 9/23/2020
Class II
PRODUCT
The Guardian Connect App CSS7200 iOS – Product Usage: intended for use by patients with a compatible consumer mobile device.
Recall Number: Z-2980-2020
REASON
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
RECALLING FIRM/MANUFACTURER
Medtronic Inc. on 7/15/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,588 users
DISTRIBUTION
International