ClearanceBrief
Recall Z-0232-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump

Tandem Diabetes Care, Inc.

t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor

DateOct 23, 2025 (initiated Aug 5, 2025)
StatusOpen, Classified
ReasonA 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.
Root causeSoftware change control
ActionOn 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 we
Quantity122,958
DistributionUS nationwide distribution including Puerto Rico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K201214t:slim X2 Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc., Jun 4, 2020
K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Tandem Diabetes Care, Inc., Feb 15, 2022
K240309Tandem Mobi insulin pump with interoperable technology
Tandem Diabetes Care, Inc., Mar 21, 2024
K241078Tandem Mobi Insulin Pump with interoperable technology
Tandem Diabetes Care, Inc., Jul 26, 2024