[pending] Tandem Mobi Insulin Pump with Interoperable Technology
Pending LLM rewrite. Source: FDA_DEVICE Z-1520-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Tandem Mobi Insulin Pump with Interoperable Technology
- Manufacturer
- Tandem Diabetes Care, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software versions 7.9/UDI: 00389152480114
Distribution
Distributed in 29 states:
- 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
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