Z-1609-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- March 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85,863 applications
Product Description
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
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 Pattern
US nationwide distribution including Puerto Rico.
Code Information
version 2.7 or later /UDI: 00850006613274