The US Food and Drug Administration (FDA) has issued a Class I recall, the most serious designation for a medical device, for Tandem Diabetes Care’s t:connect mobile app used in conjunction with its t:slim X2 insulin pump.

The t:connect Apple iOS mobile app, version 2.7, suffered a software glitch that caused the app to crash causing multiple app relaunches. This led to excessive Bluetooth usage causing battery drain and consequent shutdown of the insulin pump. The agency was clear that the recall is a software correction, not a product removal.

The 2.7 version of the t:connect app was available on Apple iOS from its release on 12 February this year through to 13 March. The recall applies to 85,863 devices in the US, as per the FDA.

The unexpected insulin shutdown resulted in the pump being unable to deliver insulin. The lack of insulin can trigger an episode of hyperglycaemia or diabetic ketoacidosis, both of which can be life-threatening. Although no deaths have been reported as of 15 April, however, 224 injuries have been recorded by the US FDA.

On March 26, Tandem alerted customers and healthcare providers using its system to update to the mobile app version 2.7.1 or later through the Apple app store. The company also cautioned its users to monitor the pump battery level closely and to charge their devices soon after the first low battery alert.  Tandem also advised its users to carry backup supplies for insulin delivery in case the pump fails.

The US diabetes market is expected to grow at a compound annual growth rate (CAGR) of 5.35% and to be worth approximately $11.6bn by 2025, as per GlobalData analysis. Abbott and Tandem are expected to drive growth by developing new devices and technologies.

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In November 2023, the US FDA issued a Class I recall for Unomedical’s Varisoft infusion sets due to a product defect that could disrupt insulin delivery from the pump. The infusion sets are used in conjunction with Tandem insulin pumps.