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Tandem Mobi Insulin Pump Correction, 3 Software Versions

Tandem Diabetes Care has issued an Urgent Medical Device Correction for Tandem Mobi insulin pumps running software versions 7.6.0.1, 7.6.0.3, and 7.7.0.1 due to false motor failure detection that can trigger Malfunction 12, stopping insulin delivery and terminating CGM communication. The FDA has classified this as a Class I recall—the most serious type—and reports four serious injuries as of November 4, 2025. Affected users must update to software version 7.9.0.2 immediately and contact Tandem at 1-877-801-6901 if Malfunction 12 occurs.