Tandem Mobi Insulin Pump with Interoperable Technology
Recall
- Recall Number
- Z-1520-2025
- Event Number
- 96417
- Firm
- Tandem Diabetes Care, Inc.
- FEI Number
- 3007981285
- Product Code
- QFG
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- February 27, 2025
- Posted
- April 11, 2025
- Address
- 12400 High Bluff Dr, San Diego, CA, 92130-3077
Description
Tandem Mobi Insulin Pump with Interoperable Technology
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.
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.
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
85 units