BEUDAMED
    FDA Enforcement Class II Ongoing

    Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

    Recall: Z-0636-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0636-2024
    Event ID
    93581
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2024
    Initiation Date
    December 6, 2023
    Classification Date
    January 4, 2024
    Address
    24 Cherry Hill Dr, N/A, Danvers, MA, 01923-2575, United States

    Description

    Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

    Reason

    The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature

    Code Info

    UDI-DI 00813502011647 Software version 1.1 - 3.17.1

    Distribution

    Domestic distribution nationwide.

    Quantity

    n/a - no physical product