PlainRecalls
FDA Devices Critical Class I Ongoing

t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

Reported: May 15, 2024 Initiated: March 5, 2024 #Z-1609-2024

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.

Details

Units Affected
85,863 applications
Distribution
US nationwide distribution including Puerto Rico.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology. Recalled by Tandem Diabetes Care, Inc.. Units affected: 85,863 applications.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 15, 2024. Severity: Critical. Recall number: Z-1609-2024.