Z-2980-2020Class II

The Guardian Connect App CSS7200 iOS -

Name: Z-2980-2020 The Guardian Connect App CSS7200 iOS -
Creator: Medtronic Inc.
Published: 2020-07-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-07-15 / Terminated / root cause: software

FDA source

Medtronic Inc. began a recall of The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device on 2020-07-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2980-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-15
Posted: 2020-09-17
Terminated: 2022-02-18
Recalling firm: Medtronic, Inc.
Product: The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: On July 15, 2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" to customers/Care Partners/Healthcare Professionals via email informing them that the Recalling Firm released an update to the CareLink Personal Software. Following the release of the software, several customer using the iOS app experienced data connectivity disruptions and as a result: 1. Care partners may not receive SMS alerts 2. Care partners remote access monitoring in the CareLink Connect web app may show data gaps 3. Customers may see data gaps in their reports. Customer are instructed to: 1. Attempt to manually upload your data to the CareLink" software via the Guardian" Connect app: a. Tap on the top left corner of the Home Screen b. Confirm Sync to CareLink is enabled c. Tap Upload Now d. Wait 10 minutes before moving to step #2. 2. Check your account to see if you are experiencing this issue a. From your mobile device visit https://carelink.minimed.eu and log in to your CareLink" account b. Confirm that your data is visible in the CareLink" Connect web app c. If your data is visible, no further action is needed - you are not experiencing the issue d. If your data is not visible, you may be experiencing the issue and you should complete the steps in the next section to resolve the issue. Instructions for Resolving the Issue (refer to the Frequently Asked Questions included for detailed instructions) 1. If your data was not visible after step #2, uninstall the Guardian" Connect app from your mobile device. For help, please refer to FAQ below #3 2. Unpair your transmitter from your mobile device. For help, please refer to FAQ below #3 3. Re-install the Guardian" Connect app on your mobile device this will restore the CareLink" connection. For help, please refer to FAQ below #4 *Uninstalling the Guardian" Connect app may delete visible data from the app. All data that has been uploaded to the CareLink" software will continue to be visible in CareLink" report
Quantity in commerce: 3,588 users
Distribution: International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, and United Kingdom. Latin America- Chile, Colombia and Mexico Asia Pacific (APAC) - Australia, India, Japan, The Republic of Korea, Malaysia, New Zealand, Russia Federation, Singapore, Thailand, and Vietnam. Asia - Hong Kong North America - Canada
Product codes and lots: Product Number - CSS7200 UDI (GTIN.UPN) - 00763000255404

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2980-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2980-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-17

Product code MDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)