Tandem Diabetes Care recalled 19 t:slim X2 Insulin Pumps on July 3, 2025, due to an app defect. The defect affects devices when set to right-to-left languages, potentially causing incorrect therapy decisions. This may lead to hypoglycemia or hyperglycemia.
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the t:slim X2 Insulin Pump with the Tandem t:slim mobile app. The devices were distributed internationally, specifically to Israel. The recall involves 19 units.
An app defect occurs when the phone is set to a right-to-left language. This defect can cause app-pump pairing issues and graphical defects, which may result in incorrect therapy decisions.
There have been no reported injuries or deaths associated with this recall. The potential risks include hypoglycemia or hyperglycemia due to incorrect insulin delivery.
Patients and healthcare providers should stop using the t:slim X2 Insulin Pump immediately. Contact Tandem Diabetes Care or your healthcare provider for further instructions.
For more information, patients can reach Tandem Diabetes Care at the contact details provided in recall notification letters. Additional details can be found at the FDA website.
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