Recall – Continuous monitoring glucose system stopped uploading data

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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.