Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
This recall has been terminated (originally issued July 4, 2018).
- Company
- Medtronic Inc.
- Recall Initiated
- July 4, 2018
- Terminated
- June 6, 2022
- Recall Number
- Z-1282-2019
- Quantity
- Approximately 9,328 registered users
- Firm Location
- Northridge, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI - (01)00643169693142(10)
Root Cause
Software design
Action Taken
A Field Corrective Action was initiated outside of the U.S. by the recalling firm's global regions on 7/4/2018.