BEUDAMED
    FDA Enforcement Class I Ongoing

    Impella RP with SmartAssist. Product Code: 0046-0035.

    Recall: Z-1469-2026 · Reported March 11, 2026

    Enforcement

    Recall Number
    Z-1469-2026
    Event ID
    98276
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abiomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2026
    Initiation Date
    January 27, 2026
    Classification Date
    February 27, 2026
    Address
    22 Cherry Hill Dr, N/A, Danvers, MA, 01923-2575, United States

    Description

    Impella RP with SmartAssist. Product Code: 0046-0035.

    Reason

    Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

    Code Info

    Product Code: 0046-0035. UDI-DI: 00813502011869.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

    Quantity

    291 units