BEUDAMED
    FDA Recall Open, Classified

    iLet Bionic Pancreas, REF: BB1001

    Recall: Z-1996-2026 · Initiated March 12, 2026

    Recall

    Recall Number
    Z-1996-2026
    Event Number
    98475
    Firm
    Beta Bionics, Inc.
    FEI Number
    3019004087
    Product Code
    QFG
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    March 12, 2026
    Posted
    April 29, 2026
    Address
    11 Hughes, Irvine, CA, 92618-1902

    Description

    iLet Bionic Pancreas, REF: BB1001

    Reason

    insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.

    Action

    On 3/12/2026, correction notices were emailed to customers who were asked to do the following: Update device software to host software 1.4.4 and up. Update your software 1. Download or update your iLet app on your phone. Read the iLet App User Guide: https://www.betabionics.com/wp-content/uploads/LA000056_F-iLet-Mobile-App-User-Guide.pdf 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. -Distributors are asked to provide patient contact information so the firm can provide the correction notice to these patients. - Complete the acknowledgment survey https://sprw.io/stt-6HnQU If you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.

    Distribution

    US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.

    Quantity

    1,080