t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a
FDA device recall Z-0232-2026 · posted 2025-10-23 · Open, Classified
Recall details
- Recalling firm
- Tandem Diabetes Care, Inc.
- Reason for recall
- A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
- Action taken
- On 8/5/2025, Field Safety Notices were sent to customers informing them of the following: Actions to avoid the issue: - Wait until your G7 sensor session ends before inserting a new G7 sensor. - However, if you do insert a new G7 sensor before your last sensor session ends, wait to pair until at least 20 minutes after the last session ends. Firm is working on a software update to resolve this issue. If you have questions or need help, please call firm's Customer Support 1-877-801-6901 or email Techsupport@tandemdiabetes.com. Our team is available 24/7/365. On 9/16/2025, correction notices were emailed to customers who were informed the firm updated user guides to align with instructions in the correction notice. Also, the firm will notify impacted users via an updated Field Correction Notice when the software update is available. The notice will provide instructions on how to remotely update their software.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- QFG
- Quantity affected
- 122,958
- Distribution
- US nationwide distribution including Puerto Rico.
- Date initiated
- 2025-08-05
- Date posted
- 2025-10-23
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tandem Mobi Insulin Pump with interoperable technology (K241078) | Tandem Diabetes Care, Inc. | 2024-07-26 |
| Tandem Mobi insulin pump with interoperable technology (K240309) | Tandem Diabetes Care, Inc. | 2024-03-21 |
| t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (K203234) | Tandem Diabetes Care, Inc. | 2022-02-15 |
| t:slim X2 Insulin Pump with Interoperable Technology (K201214) | Tandem Diabetes Care, Inc. | 2020-06-04 |