BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0232-2026 · Initiated August 5, 2025

    Recall

    Recall Number
    Z-0232-2026
    Event Number
    97403
    Firm
    Tandem Diabetes Care, Inc.
    FEI Number
    3007981285
    Product Code
    QFG
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    August 5, 2025
    Posted
    October 23, 2025
    Address
    12400 High Bluff Dr, San Diego, CA, 92130-3077

    Description

    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

    Reason

    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

    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 [email protected]. 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.

    Distribution

    US nationwide distribution including Puerto Rico.

    Quantity

    122,958