WASHINGTON—The Food and Drug Administration has issued a Class I recall for a mobile app that connects to an insulin pump.  A Class I recall is the most serious type of recall. Officials say use of these devices may cause serious injuries or death.

The recalled t:connect mobile app is an Apple iOS-based software and is for Version 2.7 of the mobile app. The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology.

The t:connect mobile app can also be used as a method of viewing pump information and limited control of the pump through compatible smartphone models, operating systems and pump software versions.

The t:slim X2 insulin pump is intended to deliver insulin under the skin (subcutaneous delivery), at set and variable rates, for the management of diabetes in persons requiring insulin. It can connect securely with other devices like insulin dosing software. The Control-IQ technology works with compatible continuous glucose monitors and pumps to adjust insulin delivery based on glucose readings, both current and predicted, and can give extra insulin as needed.

Tandem Diabetes Care, Inc. is recalling version 2.7 (released February 12, 2024 on the Apple iOS platform) of the t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology by correction. The reason for the recall is due to an issue with the software that may cause the mobile app to crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.

Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.

There have been 224 reported injuries as of April 15, 2024 and no reports of death.

Tandem Diabetes Care, Inc.  has sent all affected customers an Urgent Medical Device Correction.  The letter requested customers to:

• Update the mobile app to version 2.7.1 or later, available in the Apple App Store (to identify the software version of the t:connect mobile app, open the app, click the ‘Setting’ icon on an iPhone’s screen, and then click ‘About’).
• Complete the online formExternal Link Disclaimer to acknowledge receipt of this notice.
• Continue to use the pump as described in the User Guide and pay attention to all system alerts and alarms.
• Monitor pump battery level closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown (begin charging device after the first low battery alert).
• Always carry backup supplies for insulin delivery in the case of insulin pump failure.

Customers in the U.S. with questions about this recall should contact Tandem Diabetes Care Technical Support Team at 877-801-6901.

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