BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0636-2024 · Initiated December 6, 2023

    Recall

    Recall Number
    Z-0636-2024
    Event Number
    93581
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    PYX
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    December 6, 2023
    Posted
    January 4, 2024
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575

    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

    Action

    On December 6, 2023, the firm notified affected customers via a Correction Letter delivered by the ImpellaConnect.com portal. Customers were informed that the affected features were disabled from the web-based portal. If you have questions or concerns regarding this notice, please contact [email protected] and/or your local clinical field staff.

    Distribution

    Domestic distribution nationwide.

    Quantity

    n/a - no physical product