Z-1609-2024Class I

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

Name: Z-1609-2024 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Creator: Tandem Diabetes Care, Inc.
Published: 2024-03-05
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2024-03-05 / Open, Classified / root cause: software

FDA source

Tandem Diabetes Care, Inc. began a recall of t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology on 2024-03-05. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1609-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-05-06
Recalling firm: Tandem Diabetes Care, Inc.
Product: t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 85,863 applications
Distribution: US nationwide distribution including Puerto Rico.
Product codes and lots: version 2.7 or later /UDI: 00850006613274

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1609-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1609-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-15	2024-05-06

Product code QFG

K203234Class IIt:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. / cleared 2022-02-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)