Tandem T:Connect Recall Issued Over Software Problems Linked to More Than 200 Injuries

Federal health officials have announced a class I recall of the Apple iOS t:connect mobile app used in conjunction with X2 insulin pumps containing Control-IQ technology, due to a software error that may deplete the insulin pump battery, leading to unexpected shut downs.

The U.S. Food & Drug Administration (FDA) announced the Apple iOS t:connect mobile app recall on May 8, indicating that it may repeatedly crash and automatically relaunch, leading to excessive Bluetooth communication that can drain the battery and prevent insulin from being administered to users.

The FDA warns that a pump shutdown will interrupt insulin delivery, potentially resulting in insufficient insulin being administered. This could lead to hyperglycemia or diabetic ketoacidosis, which is a serious condition characterized by elevated blood sugars and a critical insulin deficiency.

As of April 15, there have been 224 reported injuries related to this issue. However, no deaths have been linked to the software error to date.

Apple iOS t:connect Mobile App Recall

The recalled t:connect Version 2.7 mobile app for Apple devices allows users to monitor and control their insulin pump via compatible smartphones. The app is designed to work in tandem with the t:slim X2 insulin pump, which administers insulin subcutaneously to manage diabetes. The pump’s Control-IQ technology adjusts insulin delivery based on glucose readings from connected continuous glucose monitors.

Tandem Diabetes Care, Inc. first issued an Urgent Medical Device Correction notice on March 26, notifying customers of the problem and providing instructions on how to update the mobile app to version 2.7.1 or later, available in the Apple App Store.

However, following more than 200 reported injuries reports from customers in relation to the pump shutdown events, the FDA subsequently gave the correction a Class I recall designation, indicating it is the most serious type of recall and that the use of the product could lead to life threatening injuries or death.

The t:connect recall impacts approximately 85,863 devices distributed in the U.S. from February 12, 2024 through March 13, 2024.

Customers are being encouraged to closely monitor their pump battery levels to ensure they are near full charge, and to begin charging the devices at the first sign of a low battery. Additionally, customers should always carry a backup supplies for insulin delivery in the case of insulin pump failure.

Tandem Diabetes Care is instructing customers to fill out the Mobile App v2.7 Causing Battery Depletion acknowledgement for and to contact the Tandem Diabetes Care Technical Support Team at (877) 801-6901 with any questions or concerns related to the recall.