Tandem Diabetes Care, Inc. t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Brand
Tandem Diabetes Care, Inc.
Lot Codes / Batch Numbers
version 2.7 or later /UDI: 00850006613274
Products Sold
version 2.7 or later /UDI: 00850006613274
Tandem Diabetes Care, Inc. is recalling t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology due to During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 10/09/2024, Tandem send via email an "URGENT MEDICAL DEVICE CORRECTION UPDATE" informing customers of additional actions required (uninstall and reinstall mobile app version 2.8.2) to address the faster than expected battery depletion issue. Customers are instructed to: 1.Touch and hold the app icon. 2.Tap Remove App, then tap Delete App to confirm. 3.Go to Apple App Store. 4.Search t:connect mobile to locate the t:connect mobile app. 5.Tap Download, or the cloud icon with an arrow. 6.Login with your t:connect account credentials and re-pair with your Tandem t:slim X2 pump. For complete re-pair instructions, please visit our website here. Between the dates of August 9-12, 2024, Tandem issued a Press Release and sent an "URGENT MEDICAL DEVICE CORRECTION UPDATE" Letter due to becoming aware that users may still be experiencing pump battery depletion after updating the mobile app to version 2.7.1. On August 19, 2024, Tandem issued a press release announcing the future release of the next version of the t:connect mobile app version 2.8.2. On August 20, 2024, Tandem sent a follow-up email and in-app push notification to all affected users who Tandem has a valid email announcing the release of T:connect mobile app version 2.8.2. - The customer email communication will include a URL and QR code to provide a method for users to acknowledge receipt. Between the dates of August 21, 2024 - September 4, 2024, Tandem will send an "Urgent Medical Device Correction Update" to all affected app users via First-Class Postal mail. This notification will outline the release of T:connect mobile app version 2.8.2.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026