Tandem Diabetes Care Issues Voluntary Medical Device Correction for t:slim X2 Insulin Pumps

Tandem Diabetes Care has issued a voluntary medical device correction for select t:slim X2 insulin pumps due to a speaker-related issue that may disrupt insulin delivery and CGM communication. The company has reported 700 adverse events and 59 injuries, but no fatalities. A software update will be released to mitigate the issue and improve early detection of speaker failures. Notifications have been sent to affected customers, and all pump users will be informed about the availability of the update.

SAN DIEGO, July 2, 2025 — 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. 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. 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 [1].

Notices were sent directly to impacted customers in the United States (U.S.) between July 22 and 24, 2025 with instructions on what to do in the event of a Malfunction 16. A copy of this customer notification can be found at [2]. More information, including a searchable list of serial numbers for impacted pumps, can be found at tandemdiabetes.com/mal16-2025. The U.S. Food and Drug Administration and regulatory agencies outside of the U.S. have been notified of this action.

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 risk. Tandem will notify all pump users when the software update becomes available and request that they complete the update of their insulin pump. Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at techsupport@tandemdiabetes.com or (877) 801-6901. International customers should reach out to their local distributor for more information. Contact information for each country can be found at tandemdiabetes.com [1].

The forward-looking statements in this press release, which include the plan to enhance detection of a speaker failure with this software update, the timing of this software update, and the ability to reach all of our impacted customers about this software update, are subject to numerous risks and uncertainties, including the ability to enhance detection of a speaker failure, the possibility that the rollout of the software update will be delayed, and the possibility that not every impacted customer will update their software app to this version [1].

References:
[1] https://www.nasdaq.com/press-release/tandem-diabetes-care-issues-voluntary-medical-device-correction-select-t-slim-x2
[2] https://www.tandemdiabetes.com/docs/default-source/legal/company-update/malfunction-16-speaker-issue-tslimx2-qsf0024231.pdf