regarding version 2.7 of the Apple iOS t:connect mobile app that is used in conjunction with the t:slim X2 insulin pump, which uses Control-IQ technology.
The action, a Class I recall, is the most serious type of FDA recall, indicating that"use of these devices may cause serious injuries or death," the FDA reports. On March 26, 2024, customers affected by the recall were sent an Urgent Medical Device Correction notice by Tandem Diabetes Care, Inc, requesting that they update their mobile app to version 2.7.1 or later, which is available through the Apple App Store.
For mobile apps that have already been updated to version 2.7.1 or later, no further update action is required. The t:connect mobile app works with the insulin pump with the Control-Q technology to allow viewing of pump information and limited control through smartphone and software technologies.