BEUDAMED
    FDA Recall Open, Classified

    Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM

    Recall: Z-0423-2023 · Initiated November 14, 2022

    Recall

    Recall Number
    Z-0423-2023
    Event Number
    91127
    FEI Number
    3014585508
    Product Code
    QFG
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 14, 2022
    Posted
    December 7, 2022
    Address
    Insulet Corporation 100 Nagog Park, Acton, MA, 01720-3440

    Description

    Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM

    Reason

    The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.

    Action

    On November 14, 2022, the firm initiated their Press Release at https://investor.insulet.com/news-releases/news-release-details/insulet-issues-nationwide-voluntary-medical-device-correction and notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to monitor their Omnipod 5 Controller for the following issues: - Charging port or charging cable appears melted, deformed, or discolored - Controller experiences extreme overheating (uncomfortable to hold) or emits an odor while charging If customers experience any of the issues above, they should disconnect the charger from the power outlet and do NOT charge the Omnipod 5 Controller. Promptly contact Insulet s dedicated Customer Care team specifically trained to help you at 1-800-641-2049 to request a replacement device. If you have a compatible Android smartphone (please see omnipod.com/compatibility), you may want to switch to using the Omnipod 5 App on your smartphone. Customers were provided with additional precautions to take to continue use of the device.

    Distribution

    Domestic distribution nationwide.

    Quantity

    129,086