In a significant development, the t:connect iOS app, version 2.7, used to control the t:slim X2 insulin pump, has been urgently recalled by the U.S. Food and Drug Administration (FDA). This recall falls under the Class I category, reserved for products that could potentially result in serious adverse health consequences or even death.

An insulin pump is a device designed to assist individuals with type 1 diabetes, also known as insulin-dependent diabetes. These pumps provide a more convenient and accurate method of delivering insulin compared to manual injections. The t:slim X2 pump, like other automatic pumps, is controlled by the t:connect iOS app, which determines when and how much insulin to inject based on blood sugar measurements.

The reason for the recall is a critical software bug discovered in version 2.7 of the t:connect iOS app. Users have reported frequent crashes and restarts of the app, leading to additional Bluetooth connections being established each time. This constant activity drains the pump's battery, potentially causing the device to shut down unexpectedly.

If the pump shuts down, it suspends insulin delivery, leading to a potential under-delivery of insulin. This can result in hyperglycemia or even diabetic ketoacidosis, a life-threatening condition due to high blood sugar levels and insufficient insulin.

While no fatalities have been reported thus far, the FDA has received 224 injury reports associated with the bug. To address this issue promptly, the manufacturer has released a fix in version 2.7.1 of the app, which all users are strongly advised to update to immediately.

To minimize the risk of a pump shutdown, users are also urged to ensure that their pump is fully charged before going to sleep and to charge it promptly when a low-battery alert is received.

It is essential for individuals relying on the t:connect iOS app and t:slim X2 pump to take these precautions and update to the latest version of the app to mitigate the risk of potential health complications.

For more updates on this developing story and for the latest news in the Apple ecosystem, stay tuned to 9to5Mac, your trusted source for expert coverage.