medical Class II Updated 2022-06-22

Tandem Diabetes Care Inc recalls t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim

Recalled Product

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology


Hazard / Issue

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

Issued by

FDA

Distribution: International distribution in the country of Australia.
Lot/Code Info: Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
View official government recall

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