t:slim X2 Insulin Pumps recalled due to Device Malfunction, USA

United States

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. There have been 700 confirmed adverse events, defined as a confirmed high blood sugar and/or an event requiring medical intervention, and 59 reported injuries. No deaths have been reported. The affected devices were distributed in the United States.

The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring (CGM) device. If not addressed, this could result in hyperglycemia due to discontinuation of insulin delivery, real-time CGM Estimated Glucose Values, and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional.

More information, including a searchable list of serial numbers for impacted pumps, can be found at tandemdiabetes.com/mal16-2025.

Tandem will be releasing a software update designed to enhance early detection of speaker failure. This update will also introduce persistent vibration alerts to help reduce potential safety risks. Tandem will notify all pump users when the software update becomes available and to request pump users complete the update of their insulin pump.

Important Safety Information: RX ONLY. The t:slim X2 pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater. Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller-enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.

WARNING: Control-IQ+ should not be used in anyone under the age of 2 years old with Type 1 diabetes or under the age of 18 years old with Type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.

Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an overdelivery or underdelivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tandem-diabetes-care-issues-voluntary-medical-device-correction-select-tslim-x2-insulin-pumps