Tandem Diabetes Care, Inc. is recalling approximately 122,958 t:slim X2 and Tandem Mobi insulin pumps equipped with Control-IQ+ technology. A software defect in these devices can cause the pump to deliver an unexpected automatic insulin correction bolus (autobolus) when used with a Dexcom G7 sensor. This unintended insulin delivery can lead to hypoglycemia (dangerously low blood sugar), which may require medical intervention. The recall affects t:slim X2 pumps running software versions 7.9.0.1 or 7.10.1, and Tandem Mobi pumps running software version 7.9.0.1.
The software error may trigger an incorrect dose of insulin, causing blood sugar levels to drop to dangerously low levels. Severe hypoglycemia can cause confusion, seizures, or loss of consciousness, posing a significant health risk to patients managing diabetes.
Affected User Guide versions are those not including and prior to AW-1014562 Revision D.
Affected User Guide versions are those not including and prior to AW-1014938 Revision C.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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