Recall Z-1519-2025 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology
| Date | Apr 11, 2025 (initiated Feb 27, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | 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 |
| Quantity | 63 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc., Nov 3, 2023 |