Tandem Diabetes Care, Inc. medical device recall: t:slim X2 Insulin Pump with Interoperable Technology
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96417
- Recall initiated
- Feb 27, 2025
- Classified by FDA
- Apr 11, 2025
- Posted in Enforcement Report
- Apr 23, 2025
- Recalling firm
- Tandem Diabetes Care, Inc.
- Firm location
- San Diego, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Telephone
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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 the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 27, 2025. FDA classified it 43 days later, on Apr 11, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: 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 Tandem Diabetes Care, Inc. has 12 recalls in our records.
Recalled products (2)
Z-1519-2025 Class I Ongoing
t:slim X2 Insulin Pump with Interoperable Technology
Codes / lots: Software versions 7.9/UDI: 00389152407012
Quantity: 63 units
Z-1520-2025 Class I Ongoing
Tandem Mobi Insulin Pump with Interoperable Technology
Codes / lots: Software versions 7.9/UDI: 00389152480114
Quantity: 85 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96417
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.