BEUDAMED
    FDA Recall Completed

    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

    Recall: Z-1805-2020 · Initiated May 23, 2019

    Recall

    Recall Number
    Z-1805-2020
    Event Number
    85050
    Firm
    Obalon Therapeutics Inc
    FEI Number
    3013508647
    Product Code
    LTI
    Status
    Completed
    Root Cause
    Software design
    Initiated
    May 23, 2019
    Address
    5421 Avenida Encinas, Ste F, Carlsbad, CA, 92008-4410

    Description

    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

    Reason

    During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

    Action

    To ensure that customers would receive the recall notification bulletin, and to ensure that the bulletin would not be lost in an email inbox, customers were contacted by telephone beginning on 5/23/2019 to notify them that they would be receiving an email containing the notification bulletin. These emails, first sent on 5/23/2019, contained Customer Bulletin no. LIT-7410-0025-01. The bulletin notified customers of the unintended functionality of the touchscreen during power-up, provided instructions to contact Obalon Customer Service immediately it this situation occurs, and contained updated instructions as to how to handle the device issue. Customers were instructed to contact the Obalon Customer Service/Technical Support department to obtain instructions for re-calibrating the touchscreen such that the device will function as designed and the balloon administration may proceed. Customers were requested to immediately report any events that occur with use of the system such that the firm can inform regulatory bodies and customers of any new device information and update labeling materials, where appropriate. Customers were informed that a permanent fix has been identified and once it has been reviewed and approved by FDA, all dispensers will be updated accordingly.

    Distribution

    US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ.

    Quantity

    45 units