Tandem Diabetes Care recalled 122,958 insulin pumps nationwide in the United States, including Puerto Rico. A software defect in versions 7.9.0.1 and 7.10.1 for the t:slim X2 and version 7.9.0.1 for the Tandem Mobi paired with a Dexcom G7 sensor can trigger an unexpected automatic insulin correction bolus, raising the risk of hypoglycemia. Users should stop using the affected devices and follow a)
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
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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Insulin pumps like the t:slim X2 and Tandem Mobi are CGM-integrated devices used to deliver insulin with automated features. They are widely used by adults with diabetes to manage glucose levels.
A software defect can cause an unexpected automatic insulin correction bolus, potentially driving insulin too high or too low and risking hypoglycemia.
This recall is not part of a broader industry pattern.
The defect could lead to unexpected hypoglycemia, which can be dangerous if not promptly addressed. Users may need to switch to alternative insulin delivery methods during remediation.
Recall letter and manufacturer guidance. The FDA enforcement page provides official details.
Typically 4-8 weeks for refunds or replacements after submission of a claim.
Keep the recall notice, device serial numbers, software versions, dates of purchase, and all correspondence with the manufacturer.
Brand: Tandem Diabetes Care Products: t:slim X2 insulin pump with Interoperable Technology and Control-IQ+ technology; Tandem Mobi insulin pump with Interoperable Technology and Control-IQ+ technology REF numbers: 1014070, 1014071, 1014072, 1014073 (t:slim X2); 1014801, 1014811, 1014813 (Tandem Mobi) Software versions: t:slim X2 7.9.0.1 and 7.10.1; Mobi 7.9.0.1 UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 (t:slim X2); 00389152480114, 00389152481111, 00389152481319 (Mobi) User Guide: AW-1014562 Revision D; AW-1014938 Revision C Distribution: US nationwide includingPR N
No injuries or incidents have been reported.
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