FDA Issues Most Serious Type Of Recall On App Used With An Insulin Pump

Tandem Diabetes Care Inc. is recalling version 2.7 of the t:connect mobile app that pairs with the t:slim X2 insulin pump with Control IQ technology.

The FDA has issued a recall correction for an app used with an insulin pump.

Tandem Diabetes Care Inc. is recalling version 2.7 of the t:connect mobile app that pairs with the t:slim X2 insulin pump with Control IQ technology.

The software may cause the app to crash and automatically relaunch inconsistently, which leads to excessive Bluetooth communication that may drain the pump’s battery sooner than expected.

When the pump shuts down, it stops insulin delivery. That could lead to Hyperglycemia and diabetes-related ketoacidosis, a potentially life-threatening condition caused by high blood sugar and lack of insulin.

The FDA has identified this as a Class I Recall, the most serious type of recall.

The issue has caused at least 224 injuries so far.

Impacted users and health care providers should update the app to version 2.7.1 or later and closely monitor their pump battery level.