A type of device used by more than 500,000 Americans is under scrutiny for a possible life-threatening glitch.
Recall Affecting Diabetic Patients in 29 States Receives FDA’s Highest Risk Warning
Published on Apr. 29, 2025
Though more Americans are paying attention to their blood sugar these days as a way to gauge metabolic (and therefore general) health, this practice is especially crucial for people with type 1 or 2 diabetes. National data suggests as many as 515,000 Americans depend on insulin pumps to provide consistent and accurate levels of glucose to their bodies throughout each day.
The Cleveland Clinic explains that insulin pumps, used most often by type 1 diabetes patients, helps play the role of the pancreas by releasing insulin. But too much or little of insulin can lead to significant health consequences.
Earlier this month, the FDA announced a recall for two types of insulin pumps, citing a concerning software defect. The pumps—t:slim X2 Insulin Pump with Interoperable Technology and Tandem Mobi Insulin Pump with Interoperable Technology—have been recalled by Tandem Diabetes Care, Inc. of San Diego, California.
Only 148 total devices appear to be officially affected, but the implications behind the recall suggest insulin pump users should confirm their device isn’t involved.
In short, the devices’ problems appear to be connected to a software defect with the potential to either deliver too much insulin to pump wearers (which could result in hyperglycemia, or high blood sugar) or too little insulin (with the potential for hypoglycemia, or low blood sugar).
The FDA has designated this as a Class I risk level. Class I is reserved for the most serious events in which FDA experts determine that products “could cause serious health issues or death.” Severe cases of hypoglycemia and hyperglycemia both can be extremely dangerous—and even life-threatening.
The FDA provided the following product details:
t:slim X2 Insulin Pump with Interoperable Technology
- Software versions 7.9
- UDI (Unique Device Identification): 00389152407012
- Total units recalled: 63
Tandem Mobi Insulin Pump with Interoperable Technology
- Software versions 7.9
- UDI: 00389152480114
- Total units recalled: 85 units
The products were reportedly distributed in the following 29 states: 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, Wisconsin.
More specifics behind the recall, from the FDA’s report: “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.”
It is not clear whether any adverse events have been reported to the FDA in connection to this recall event, which according to the report was first initiated on February 27.
In 2024, the FDA advised the public about a mobile app issue affecting the battery life of insulin pumps made by the same company.
The FDA does not provide recommendations for what users should do if their insulin pump is affected, but concerned consumers can reach out to Tandem Diabetes Care via their online support page.
If you or someone you know is potentially experiencing a medical emergency, always dial 911.
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