medical Class I Updated 2025-04-23

Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump with Interoperable Technology

Recalled Product

Tandem Mobi Insulin Pump with Interoperable Technology


Hazard / Issue

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.

Issued by

FDA

Affected 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
Lot/Code Info: Software versions 7.9/UDI: 00389152480114
View official government recall

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