This recall constitutes a correction, not a product removal.
Tandem recalled Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 pump with Control-IQ technology. It initiated the recall on March 18, 2024, with affected devices distributed between Feb. 12, 2024, and March 13, 2024. In total, the recall extends to 85,863 devices in the U.S.
According to an FDA notice, Tandem recalled the software version because of an issue that may cause the mobile app to crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication. That may result in pump battery drain, potentially leading to the pump shutting down sooner than typically expected.
Pump shutdown could cause insulin delivery to suspend, which may lead to an under-delivery of insulin. That, in turn, could result in hyperglycemia or diabetic ketoacidosis, a potentially life-threatening condition due to high blood sugars and lack of insulin.
Tandem received reports of 224 injuries as of April 15, 2024, with no deaths reported to date.
Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin.
t:slim X2, an automated insulin delivery system, utilizes Control-IQ technology that predicts glucose levels every 30 minutes into the future. It automatically adjusts insulin delivery every five minutes based on CGM readings. The technology can also deliver automatic correction boluses (up to one per hour) to help prevent hyperglycemia.
The iOS app works with the pump and Control-IQ software and can provide a method of viewing pump information, plus limited control of the pump.
Tandem instructed customers to update the mobile app to version 2.7.1 or later, available in the Apple App Store. Users should monitor their pump battery level closely to help prevent pump shutdown. They should also begin charging the device after the first low battery alert.
