Recall archive / FDA device enforcement
t:slim X2 Insulin Pump with Interoperable Technology — FDA record Z-1519-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- t:slim X2 Insulin Pump with Interoperable Technology
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Tandem Diabetes Care, Inc.
- Quantity
- 63 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1519-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Software versions 7.9/UDI: 00389152407012 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 23, 2025
- Recall initiation date
- Feb 27, 2025
- Center classification date
- Apr 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.