FDA recall Z-1282-2019

Medtronic Inc. · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2019