Tandem recalls Mobi insulin pump, reports 230 adverse events

Dive Brief:

Tandem Diabetes Care issued a correction for more than 80,000 Mobi insulin pumps for a problem that can interrupt insulin delivery to patients.
The company began a recall in late September because certain Mobi insulin pumps may have a false occlusion alarm, suspending insulin delivery until the user acknowledges the alarm and resumes therapy. Repeat false alarms can increase the risk of high blood glucose levels, the Food and Drug Administration said in an Oct. 30 database entry.
Tandem has received reports of 230 adverse events requiring medical intervention or hospitalization as of Oct. 29, a company spokesperson wrote in an email to MedTech Dive. No deaths have been reported.

Dive Insight:

The latest recall applies to more than 80,900 Mobi devices, most of which were distributed in the U.S., according to the FDA’s database entry. While the database provided a list of serial numbers for pumps with frequent false alarms to be exchanged, the entry also noted that “all affected pump models and serial numbers may be affected.”

Tandem found that increased friction within the pumps’ drive module can reduce available motor power, and under certain conditions, may cause the motor speed to fall below the occlusion detection threshold, triggering a false alarm. The company has told customers that they may continue to use their Mobi devices, but must always respond to an occlusion alarm and have a backup method of insulin delivery. If the occlusion alarms continue after troubleshooting, or repeatedly disrupt insulin therapy, Tandem has instructed users to contact customer support.

Tandem is investigating the issue and has taken steps during testing to prevent the problem in the future, a spokesperson wrote in an email.

Tandem grappled with a separate software malfunction a year ago that could affect insulin delivery from its Mobi devices, instructing users to install an update to fix the issue. The company sent a letter to customers in October 2025, but the FDA posted it in its recall database in April.

A tubeless option for Mobi is in the late stages of FDA review, CEO John Sheridan said in an earnings call last week. Tandem named a new incoming CEO who will join the company this month as it prepares for the launch of its first tubeless device.