The U.S. Food and Drug Administration has classified a corrective action involving insulin pumps from Tandem Diabetes Care Inc. (NASDAQ:TNDM) as a Class I recall, the agency’s most serious designation, citing risks of serious injury or death if the issue is not addressed.
The recall does not involve removing products from the market. Instead, it focuses on correcting affected devices currently in use.
Device Overview
Tandem’s insulin pumps are battery-operated devices designed to deliver both basal and bolus insulin through a motor-driven system, using a cartridge and infusion set to administer insulin subcutaneously.
Affected Devices And Required Action
The FDA said Tandem issued an urgent medical device correction for its Mobi insulin pumps running software versions 7.6.0.1, 7.6.0.3, and 7.7.0.1.
Customers are advised to update their pump software immediately to version 7.9.0.2, which includes quality improvements.
The update is available through the Tandem Mobi mobile app.
Users are also instructed to have a backup insulin delivery method ready and continue using the pump with caution if no malfunction has occurred.
Malfunction Risk May Halt Insulin Delivery
Tandem said the issue stems from a potential “false motor failure” detection. The pump’s system monitors electrical current in its vibration motor, which provides alerts and feedback.
If the system incorrectly detects irregular current levels, it may trigger a “Malfunction 12” alert. This causes the pump to stop insulin delivery and become non-operational.
The malfunction also disrupts communication with continuous glucose monitoring devices and the associated mobile app, limiting access to glucose data.
Health Risks And Reported Cases
If insulin delivery is interrupted and not promptly addressed, patients may experience hyperglycemia. In severe cases, this could require hospitalization or medical intervention.
As of November 4, 2025, Tandem reported four serious injuries linked to the issue. No deaths have been reported.
Guidance For Users Experiencing Alerts
Patients encountering a Malfunction 12 alert should silence the alarm, contact Tandem support, and switch to an alternative insulin delivery method as directed by their physician.
Regular blood glucose monitoring is also recommended to detect abnormal levels early.
TNDM Stock Price Activity: Tandem Diabetes shares were down 1.89% at $20.29 at the time of publication on Friday, according to Benzinga Pro data.
Photo via Shutterstock
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