Insulin pumps recalled over false vibration motor failure stopping delivery

Plain-English summary

Tandem Mobi Insulin Pumps running software versions 7.6.0.1, 7.6.0.3 and 7.7.0.1 are being recalled, across catalog numbers including 1010750, 1012719, 1013501, 1013655, 1013656, 1013700 and 1014081. The pumps are battery-operated infusion pumps that deliver basal and bolus insulin from a disposable cartridge through an infusion set.

The pump includes a vibration motor that gives tactile feedback for alerts, alarms and malfunctions. A software issue may cause the pump to exhibit a false vibration motor failure, triggering Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped." Tandem states this could result in hyperglycemia.

The recall covers 17,745 pumps distributed across the United States including Puerto Rico and the Virgin Islands. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.

People using a Tandem Mobi pump should check their software version and follow Tandem's instructions.

The recalled product

Product

Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,

Manufacturer

Tandem Diabetes Care, Inc.

Category

Medical Device — Insulin pump

Hazard

• software-defect
• delivery-stopped
• hyperglycemia
• class-i
• diabetes

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls