Tandem Diabetes Care, Inc. Recall 96417
Description: t:slim X2 Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc. Recall 96417 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1519-2025 |
| Event ID | 96417 |
| Event Description | t:slim X2 Insulin Pump with Interoperable Technology |
| Product Type | Devices |
| 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 |
| Quantity | 63 units |
| Recall 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. |
| Device Classification | 20250423 |
| Device Code Info | Software versions 7.9/UDI: 00389152407012 |
| Center Classification Date | 20250411 |
| Recall Initiation Date | 20250227 |
| Recalling Firm | Tandem Diabetes Care, Inc. |
| Initial Notification | Telephone |
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