Tandem Recalls Diabetes Pump’s iOS App After Reports of 224 Injuries

Tandem Diabetes Care has issued a recall of its t:connect iOS app after reports of 224 injuries related to the software.

Version 2.7 of the app had a flaw that led it to repeatedly crash and restart, excessively draining the battery of the company’s t:slim X2 insulin pump by overusing the Bluetooth connection. That shuts down the insulin supply earlier than expected, leading to major reactions like hyperglycemia or diabetic ketoacidosis. That could threaten wearers’ lives, the U.S. Food and Drug Administration (FDA) said.

Tandem hasn’t had any reports of deaths before the recall. It has already fixed the iOS app with version 2.7.1, and sent a warning to users on March 26th urging them to both update and keep a close watch on the pump’s battery level.

The FDA marked the Tandem notice as its most urgent “Class I” recall reserved for products that could cause serious or fatal injuries. It stressed that the physical product would remain available.

The Tandem recall nonetheless underscores the complications that sometimes arise with connected healthcare devices. Software bugs and other technical issues can pose real risks, whether it’s making someone ill or improperly diagnosing conditions. Regulators like the FDA can approve solutions as well as launch recalls, but there’s still a possibility (however small) that flaws might emerge through updates.