The software glitch may cause the iOS app, known as t:connect, to repeatedly crash and relaunch. This cycle can drain the insulin pump’s battery and cause it to shut down sooner than expected, suspending insulin delivery for users and putting them at risk of hyperglycemia or diabetic ketoacidosis.
As of April 15, the FDA has received 224 reports of injuries tied to the device. No deaths have been reported.
The recall affects more than 85,000 app users. On March 26, Tandem Diabetes Care notified users of the issue and asked them to update to a newer version of the app.
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