FDA-Device2024-05-15Class I
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Tandem Diabetes Care, Inc.
Hazard
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.
Sold states
US nationwide distribution including Puerto Rico.
Affected count
85,863 applications
Manufactured in
11075 Roselle St, N/A, San Diego, CA, United States
Products
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief