FDA Recalls Insulin Pump App After Numerous Injuries
CALIFORNIA (May 9, 2024) — The FDA has announced a Class I recall — the most critical type — of the t:connect app version 2.7, used with the t:slim X2 insulin pump, after 224 reported injuries. This recall affects over 86,000 devices across the U.S. and involves a software correction rather than a complete product removal.
Tandem Diabetes Care Inc., the developer of the app, identified a flaw where the app may crash and restart repeatedly. This error leads to excessive Bluetooth communication, which can drain the insulin pump’s battery and cause abrupt shutdowns. Interruptions in insulin delivery due to such shutdowns raise the risk of severe health issues, including hyperglycemia and diabetic ketoacidosis.
The company has urged all users to update their app to version 2.7.1 or later, available on the Apple App Store, and to fill out an online form to confirm they’ve received this notice. Users are advised to monitor their pump’s battery level closely and carry backup insulin delivery supplies.
For further assistance or information about the t:connect insulin pump app recall, customers can contact Tandem Diabetes Care Inc. at (877) 801-6901.
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