Tandem Mobi Insulin Pump (Tandem Diabetes) – Software Defect (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tandem Mobi Insulin Pump with Interoperable Technology
Brand
Tandem Diabetes Care, Inc.
Lot Codes / Batch Numbers
Software versions 7.9/UDI: 00389152480114
Products Sold
Software versions 7.9/UDI: 00389152480114
Tandem Diabetes Care, Inc. is recalling Tandem Mobi Insulin Pump with Interoperable Technology due to 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 th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On February 28, 2025 Tandem Diabetes Care contacted each affected customer by phone concerning a Urgent Medical Device Correction. On March 11, 2025, Tandem followed up with a "Urgent Medical Device" Recall notification via E-Mail to affected consignees. Tandem ask consignees to take the following action: 1. Turn off Control-IQ+ immediately. You may continue to use your pump without Control-IQ active. Your pump will deliver insulin based on your programmed active personal profile and will not automatically adjust insulin delivery. 2. Please refer to the user guide provided with your pump for more detailed instructions. 3. Continue using your Tandem pump as described in the User Guide. 4. Pay attention to all system alerts and alarms. 5. Always carry back-up supplies.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, CT, FL, HI, ID, IL, IN, IA, ME, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, ND, OH, PA, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026