Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery
Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I medical device recall. The defect can cause severe adverse health consequences including severe hypoglycemia and hyperglycemia due to incorrect insulin delivery—a critical function of the device—which meets the Class I criteria and warrants a Severe severity rating.
Plain-English summary
Tandem Diabetes Care, Inc. is recalling the Tandem Mobi Insulin Pump with Interoperable Technology due to a software defect in version 7.9. The defect affects pumps used with Control IQ+ technology.
The software defect causes the pump to incorrectly interpret glucose trends when the Estimated Glucose Value is above 255 mg/dL at the start or end of a data collection gap due to a lapse in connection from a paired continuous glucose monitor sensor. This inaccurate interpretation can lead to under-delivery or over-delivery of insulin.
The incorrect insulin delivery can result in severe cases of hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). A total of 85 units have been distributed across multiple U.S. states including Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin.
Patients using the affected pump should contact Tandem Diabetes Care, Inc. for software update guidance and further instructions.
The recalled product
- Product
- Tandem Mobi Insulin Pump with Interoperable Technology
- Manufacturer
- Tandem Diabetes Care, Inc.
- Hazard
- insulin-delivery-error
- hypoglycemia
- hyperglycemia
- software-defect
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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