# FDA recall Z-2980-2020

> **Medtronic Inc.** · Class II · device recall initiated 2020-07-15.

## Product

The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

## 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.

## 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

## Key facts

- **Recall number:** Z-2980-2020
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-15
- **Report date:** 2020-09-23
- **Termination date:** 2022-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2980-2020

## Citation

> AI Analytics. FDA recall Z-2980-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2980-2020. Source: US FDA. Licensed CC0.

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