FDA Posts Class I Notice for Tandem Mobi Insulin Pump Software Correction

The US Food and Drug Administration has posted a notice identifying Tandem Diabetes Care's correction of certain Tandem Mobi insulin pumps as the most serious type of recall, according to the agency's recall page, dated April 22. The action covers Mobi pumps running software versions 7.6.0.1, 7.6.0.3 and 7.7.0.1.

The recall involves correcting devices rather than removing them from use, the FDA said. According to the notice, the recall was classified on November 5, 2025, and Tandem sent affected customers an Urgent Medical Device Correction on October 6, 2025.

A false motor failure

Tandem stated that pumps on the affected software "may incorrectly detect a motor issue, known as a false motor failure," the FDA said. The Mobi pump has a vibration motor that gives tactile feedback for alerts, alarms and malfunctions, and the pump's software monitors the electric current flowing through that motor. If the current is detected as out of range, the pump triggers a malfunction alert known as Malfunction 12.

"If your Tandem Mobi pump shows Malfunction 12, insulin delivery will stop, and the pump becomes non-operational," the notice says. The malfunction also ends communication between the pump and the continuous glucose monitor and the Tandem Mobi mobile app. The FDA said that if not addressed, this could result in hyperglycemia, and that in severe cases a user may require hospitalization or intervention from a medical professional.

"As of November 4, 2025, Tandem Diabetes Care has reported four serious injuries, and no deaths associated with this issue," the agency said.

Software update as the fix

The notice lists seven affected catalog entries, including standard, replacement and Medicare versions of the Mobi pump with Control-IQ and a pharmacy starter kit. Tandem's letter told customers to update to software version 7.9.0.2, which the company offers as a free download through the Mobi mobile app, and to have a backup method of insulin delivery ready. Users who receive a Malfunction 12 alert were told to silence the alarm, contact Tandem and switch to their backup method, the notice says.

MedTech Dive reported on April 22 that more than 17,700 devices were affected, according to an FDA enforcement report. The publication noted that the Mobi, a small tubed pump operated from a smartphone, received FDA clearance in 2023, and that it is one of several diabetes device safety problems flagged by the agency this year, including Insulet's March recall of Omnipod 5 pumps over internal tubing tears.