Tandem Mobi Insulin Pump Recall Issued Following Multiple Serious Injuries

FDA announcement is the latest in a string of insulin pump and continuous glucose monitoring system recalls or warnings issued this year.

Federal health officials warn that software malfunctions in the Tandem Mobi insulin pump may disrupt insulin delivery, increasing the risk of hyperglycemia and other serious health complications.

The U.S. Food and Drug Administration (FDA) announced the Tandem Mobi insulin pump device correction on April 22, classifying the action as a Class I recall. This indicates the problems could put patients at risk of serious injury or death.

Tandem Mobi Insulin Pump Recall

Insulin pumps are small, battery-powered wearable devices used to manage diabetes and deliver insulin to users around the clock. The pump monitors a patient’s insulin levels through a continuous glucose monitor (CGM) and delivers insulin through a small catheter attached under the skin.

However, reports indicate the Tandem Mobi insulin pump’s software can issue a false “Malfunction 12” warning. This occurs when the pump incorrectly detects a motor issue in the device. The motor is used to vibrate, alerting the user of “out of range” levels during monitoring.

If the Malfunction 12 alert is triggered, insulin delivery will stop and the pump will cease functioning. It will also stop communication between the pump and CGM devices, as well as between the pump and the Mobi app. If insulin delivery stops, a user could suffer from hyperglycemia and may require medical treatment or hospitalization. To date, four serious injuries have been reported.

Tandem first issued an Urgent Medical Device Correction notice to users in October 2025. However, because the manufacturer’s notice was a device correction, which involves updating or correcting affected devices, the pumps are not being removed from the market.

The recall affects the Tandem Mobi, Control IQ devices with catalog numbers:

• 1010750
• 1012719
• 1013501
• 1013655
• 1013656
• 1013700

It also affects Tandem Mobi starter packs with catalog number 1014081.

Federal health officials recommend updating the insulin pump’s software to version 7.9.0.2 as soon as possible, and they are urging users to be prepared with a backup method of insulin delivery. Users should regularly check their blood sugar to ensure they are not having unexpectedly high or low readings.

Individuals who have not had a Malfunction 12 alert should continue using their Tandem insulin pumps with added precautions, since the Malfunction 12 can occur at any time.

The software can be downloaded remotely from within the Tandem Mobi Mobile App. Users can contact Tandem at 877-801-6901 with questions about the software malfunction.

Insulin Pump Problems

Other insulin pumps and diabetes monitoring devices have suffered issues in recent months that have led to injuries, numerous recalls and product liability lawsuits.

The FDA announced an Insulet Omnipod 5 insulin pump recall in March, due to damaged internal components that could cause both under-delivery and over-delivery of insulin. At the time of the recall, federal regulators had confirmed at least 18 reports of serious injuries tied to defective pods for the devices.

As a result, Omnipod injury lawyers are now investigating potential lawsuits against the manufacturer for failing to properly design, test or warn about the risk of insulin delivery failures associated with the pods.

In addition, dozens of lawsuits have been filed against Abbott Laboratories for malfunctions connected to defective sensors in the Freestyle Libre 3 CGM.

These defects may cause false hyperglycemic readings which have led to more than 700 user injuries, as well as multiple deaths. Lawyers are also investigating Freestyle Libre 3 lawsuits for those who have suffered injuries due to the product’s defect.  

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