Tandem Diabetes Care has issued an urgent correction affecting more than 80,000 Tandem Mobi insulin pumps due to an issue that can interrupt insulin delivery. According to the FDA, certain Mobi pumps may generate false-positive occlusion alarms even when there is no actual obstruction to insulin flow. The issue is caused by increased friction within the pump's drive module, which can reduce motor power and cause the pump to incorrectly detect an occlusion. When this happens, insulin delivery is suspended until the user acknowledges the alarm. Repeated interruptions can increase the risk of elevated blood glucose levels. As of October 29, 2026, Tandem reported 230 adverse events requiring medical intervention or hospitalization. No deaths have been reported.

Tandem has instructed affected users to respond to occlusion alarms and follow the troubleshooting steps in the pump's user guide, and contact Tandem Customer Support if they experience repeated occlusion alarms, so the pump can be exchanged. Users should also be prepared with a backup method of insulin delivery.

This is not the first recent issue involving Tandem's Mobi system. In October, Tandem issued a separate urgent correction for Android app users after identifying a software issue that could prevent the immediate portion of an Extended Bolus from being delivered. That issue did not affect iOS users. And in April, Tandem issued another urgent correction due to a software issue that prevented the pump from delivering insulin properly. The latest recall comes as the upcoming tubeless mobi is awaiting FDA clearance.

This is a developing story.