Tandem Diabetes Care, Inc. recalls t:slim X2 insulin pump with Interoperable Technology

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0232-2026
• FDA 510(k) clearance · K201214The device's official FDA premarket clearance record
• FDA 510(k) clearance · K203234The device's official FDA premarket clearance record
• FDA 510(k) clearance · K240309The device's official FDA premarket clearance record
• FDA 510(k) clearance · K241078The device's official FDA premarket clearance record
• FDA device classification · QFGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5730The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tandem Diabetes Care, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.