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

Recall date

July 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1282-2019

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

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, Nor…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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