t:slim X2 Insulin Pump with Interoperable Technology Recall
Issued April 23, 2025 · Tandem Diabetes Care, Inc.
In April 2025, Tandem Diabetes Care, Inc. recalled the t:slim X2 Insulin Pump with Interoperable Technology, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
What you should do
- 1 Stop using t:slim X2 Insulin Pump with Interoperable Technology right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Tandem Diabetes Care, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Tandem Diabetes Care, Inc.
- Category
- Health
- Recall date
- April 23, 2025
- Units affected
- Not reported
- Sold at
- US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
- Recall number
- FDA-Z-1519-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Tandem Diabetes Care, Inc. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.