FDA issues 'most serious type of recall' for insulin pump-related iOS app

The "correction" as referred to by the FDA on Wednesday, rather than a product removal, relates to the t:connect Mobile App iOS v2.7. It was confirmed by Tandem Diabetes Care the following day, which stated that Android app users are not included in the recall.

"The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology," the FDA states. The pump delivers insulin under the skin at set and variable rates for the management of diabetes. 

The app recall is due to a software issue that may cause the app to crash and be automatically relaunched which "may result in pump battery drain and may lead to the pump shutting down sooner than typically expected."