t:slim X2 insulin pumps
Product details
- t:slim X2 insulin pumps
Company announcement
Tandem Diabetes Care, Inc. announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue.
The issue can trigger an error, Malfunction 16, resulting in a discontinuation of insulin delivery.
Impacted customers in the United States were notified between July 22 and 24, 2025.
59 injuries have been reported.
Risk:
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.
Impacted states: Nationwide
Products:
- t:slim X2 insulin pumps
Contact
For more information, call (877) 801-6901 or email techsupport@tandemdiabetes.com.