FDA Device recall Z-1520-2025
Tandem Mobi Insulin Pump with Interoperable Technology
- FDA Device
- Class I
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class I recall of Tandem Mobi Insulin Pump with Interoperable Technology by Tandem Diabetes Care, citing 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 interpo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1520-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-27 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tandem Diabetes Care |
| Distribution | 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 |
Product
Tandem Mobi Insulin Pump with Interoperable Technology
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.
Identifiers
| code_info | Software versions 7.9/UDI: 00389152480114 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1520-2025%22
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