t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
FDA device recall Z-2621-2025 · posted 2025-09-24 · Open, Classified
Recall details
- Recalling firm
- Tandem Diabetes Care, Inc.
- 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.
- Action taken
- On 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QFG
- Quantity affected
- 19
- Distribution
- International distribution to the country of Israel.
- Date initiated
- 2025-07-03
- Date posted
- 2025-09-24
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| t:slim X2 Insulin Pump with Interoperable Technology (K232380) | Tandem Diabetes Care, Inc. | 2023-11-03 |