Insulin pump app recall announced following 220+ injuries

Insulin pump app recall overview: 

• Who: Tandem Diabetes Care recalled its t:connect Apple iOS mobile app used with the t:slim X2 insulin pump. 
• Why: The app crashes and automatically relaunches, causing the pump to shut down and leading to under-delivery of insulin. The app issues can also cause excessive Bluetooth communication and battery depletion.
• Where: The insulin pump app injuries recall applies across the United States.

Tandem Diabetes Care recalled its t:connect Apple iOS mobile app used with the t:slim X2 insulin pump because the app can crash, causing battery depletion and under-delivery of insulin.

The issues have led to 224 insulin pump app injuries. The crashes can cause individuals to develop hyperglycemia or even diabetic ketoacidosis, a potentially life-threatening condition stemming from high blood sugar and lack of insulin.

The recall is for version 2.7 of the iOS app, which was released Feb. 12.

Make sure pump is fully charged before going to sleep, recall says

Tandem Diabetes Care sent customers an Urgent Medical Device Correction on March 26, telling customers to update the app to version 2.7.1 or later. Customers should then complete an online form to say they updated the app then carefully monitor the pump’s battery level and ensure the pump is at or near full charge before going to sleep.

Tandem Diabetes Care says it has received 224 reports of injury related to the recall as of April 15 and no reports of death. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

The Tandem Diabetes Care Technical Support Team can be reached by phone at 877-801-6901.

Abiomed, another medical device technology company, issued an April recall for the instructions of 66,390 Impella left-side heart pumps connected to 49 reports of death and 129 reported serious injuries. 

Are you affected by the insulin pump app recall? Let us know in the comments. 

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