SAN DIEGO, CA — Tandem Diabetes Care has issued a recall correction for more than 80,000 Mobi insulin pumps after identifying a problem that can stop insulin delivery when the device gives a false occlusion alarm. The company said the issue can pause therapy until a user acknowledges the alert and resumes treatment.
The Food and Drug Administration said repeated false alarms can raise the risk of high blood glucose levels. Tandem reported 230 adverse events that required medical intervention or hospitalization as of Oct. 29, according to a company spokesperson. No deaths have been reported.
FDA says most affected pumps were distributed in the U.S.
The FDA’s Oct. 30 database entry said the latest recall covers more than 80,900 Mobi devices, the vast majority of which were distributed in the United States. The agency also published a list of serial numbers for pumps that had frequent false alarms and are to be exchanged.
At the same time, the agency noted that the problem may not be limited to those serial numbers. In its entry, the FDA said that all affected pump models and serial numbers may be affected, widening the scope of the correction beyond the most easily identified units.
Tandem said customers can continue using their Mobi devices, but they must always respond to an occlusion alarm and keep a backup method of insulin delivery available. If the alarms keep happening after troubleshooting, or if they repeatedly interrupt insulin therapy, the company has told users to contact customer support.
Friction inside the drive module is blamed for the false alarms
Tandem said it found that increased friction inside the pump’s drive module can reduce the motor power available to the device. Under certain conditions, that can cause motor speed to drop below the threshold used to detect an occlusion, which then triggers a false alarm.
The company said it is still investigating the problem and has already taken steps in testing intended to prevent the issue from happening again. A spokesperson said those preventive changes are part of Tandem’s work to address the defect while the recall remains in place.
The company has not reported any deaths linked to the issue, but the FDA said the repeated alarms can interrupt insulin delivery long enough to create medical risk for patients who rely on the pumps for therapy.
Tandem warns users to keep backups ready and respond immediately to alarms
The recall guidance is meant to reduce the chance that interrupted insulin delivery leads to complications. Tandem told users to acknowledge every occlusion alarm and to have another way to deliver insulin if the pump stops working as expected.
If alarms continue after troubleshooting, or if they repeatedly disrupt therapy, customers should reach out to Tandem support for help. The company’s instructions reflect the seriousness of any interruption in delivery, especially for patients who depend on the device throughout the day and night.
That advice came alongside the recall correction, which is designed to keep patients informed while Tandem and regulators work through the scope of the problem and the best way to manage affected devices already in use.
The recall follows an earlier software problem tied to Mobi devices
The latest action is not the first time Tandem has had to address a Mobi-related issue. About a year ago, the company dealt with a separate software malfunction that could affect insulin delivery from the same devices. At the time, users were told to install an update to correct the problem.
Tandem sent a letter to customers about that issue in October 2025, and the FDA later posted it in its recall database in April. That history adds context to the current correction as the company works through another safety problem involving the same product line.
The repeat appearance of device problems comes as Tandem prepares for another major product step. The company has said a tubeless option for Mobi is in the late stages of FDA review.
New leadership and a tubeless launch are part of Tandem’s next phase
Chief Executive Officer John Sheridan said on an earnings call last week that the tubeless version of Mobi is moving through the final stages of review at the FDA. The company has also named a new incoming CEO who is set to join this month.
Those moves come as Tandem prepares for the launch of its first tubeless device, a shift that could broaden the company’s insulin pump lineup. For now, though, the focus remains on the recall correction, the investigation into the false alarms, and the instructions patients are being given to keep therapy running safely.
With more than 80,000 devices covered and hundreds of adverse events reported, the recall is a significant step for one of the company’s flagship products and a reminder of how sensitive insulin delivery systems can be to technical failures.
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