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