# FDA recall Z-1282-2019

> **Medtronic Inc.** · Class II · device recall initiated 2018-07-04.

## Product

Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

## Reason for recall

The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.

## Distribution

Distribution was only made OUS.  Countries involved are:  Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, Norway, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Turkey, and South Africa.

## Key facts

- **Recall number:** Z-1282-2019
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-04
- **Report date:** 2019-05-15
- **Termination date:** 2022-06-06

- **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-1282-2019

## Citation

> AI Analytics. FDA recall Z-1282-2019. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1282-2019. Source: US FDA. Licensed CC0.

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