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U.S. Department of Health and Human Services

Class 2 Device Recall t:slim X2 insulin pump with Interoperable Technology

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 Class 2 Device Recall t:slim X2 insulin pump with Interoperable Technologysee related information
Date Initiated by FirmJuly 03, 2025
Date PostedSeptember 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2621-2025
Recall Event ID 97264
510(K)NumberK232380 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
Productt:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Code Information Tandem t:slim Mobile App, Android Software Version 2.9.1 UDI-DI code: 00389152470641 Serial Numbers / Cell Phone OS: 1163923 Google Pixel 8 Pro husky [15 35] 1164430 samsung SM-S901E r0qxxx [15 35] 1167131 samsung SM-A346E a34xdxx [14 34] 1299238 samsung SM-G780G r8qxx [13 33] 1300180 samsung SM-S928B e3qxxx [15 35] 1300180 samsung SM-S928B e3qxxx [14 34] 1329242 Google Pixel 6 Pro raven [15 35] 1381313 samsung SM-G780G r8qxx [13 33] 1381315 Google Pixel 9 tokay [16 36] 1381537 samsung SM-A546E a54xnsxx [14 34] 1381570 Xiaomi 2407FPN8EG rothko_global [15 35] 1391808 samsung SM-S711B r11sxxx [14 34] 1391892 samsung SM-N980F c1sxx [13 33] 1392863 samsung SM-S926B e2sxxx [15 35] 1392953 samsung SM-S916B dm2qxxx [15 35] 1393040 samsung SM-S901E r0qxxx [15 35] 90615975 realme RMX3241 RMX3241 [13 33] 90754587 samsung SM-S916B dm2qxxx [15 35] 901144584 samsung SM-S901E r0qxxx [14 34]
Recalling Firm/
Manufacturer		 Tandem Diabetes Care, Inc.
12400 High Bluff Dr
San Diego CA 92130-3077
For Additional Information ContactMs. Susan Morrison
858-366-6880
Manufacturer Reason
for Recall		an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
FDA Determined
Cause 2		Software design
ActionOn 07/03/2025, the firm sent an "URGENT FIELD SAFETY NOTICE" it distributor to notify customers that users operating an Android phone with language setting set as Hebrew may experience a blank screen on the mobile application during the initial pairing sequence. The language setting must be set to English for the pairing sequence to work successfully. However, if users set their language back to a right-to-left language after pairing, or do not encounter the initial issue, the mobile application will display discrepancies. This discrepancy may cause a user to make incorrect therapy decisions that may result in under-delivery or over-delivery of insulin. Customers are instructed to: If you are operating the Tandem t:slim mobile app version 2.9.1 on an Android smartphone, and your device language is set to a right-to-left language, please revert your phone language setting to English. You can do this by navigating to the Settings app on your device. If you are unable to or do not want to change your phone language to English, Tandem recommends not to use the Android Tandem t:slim mobile app version 2.9.1 until a future update addresses this issue. Additional Recommended Best Practices: 1. Continue using your Tandem pump as described in the User Guide. 2. Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. 3. Pay attention to all system alerts and alarms. 4. Always carry back-up supplies. For questions or assistance - Additional information of this Field Safety Notice is available by contacting Padagis at Inbal.hadasheli@padagis.com.
Quantity in Commerce19
DistributionInternational distribution to the country of Israel.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QFG
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