Medical Device Recall: t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Tandem Diabetes Care, Inc. · March 5, 2024
Reason for Recall
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Distribution
US nationwide distribution including Puerto Rico.
States Affected
NATIONWIDE
Quantity Affected
85,863 applications
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1609-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.