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Update:Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
Please be aware, this recall is a correction, not a product removal.
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On August 9, 2024, Tandem Diabetes Care issued an "Urgent Medical Device Correction Update” notification to inform users and healthcare providers that users may still be experiencing occurrences of t:slim X2 insulin pump battery depletion after updating their t:connect mobile app to version 2.7.1.
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On August 20, 2024, Tandem Diabetes Care released version 2.8.2 of its Apple iOS t:connect mobile app in the United States to correct the issue.
Tandem Diabetes Care, Inc. is recalling version 2.7 (released February 12, 2024, for devices using the Apple iOS platform) of the t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology. This recall is a correction and not a product removal. The reason for the recall is due to an issue with the software that may cause the mobile app to 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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal.
Questions?
If you have questions about this recall, contact Tandem Diabetes Care Technical Support Team at (877) 801-6901.
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