BEUDAMED
    FDA Recall Terminated

    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

    Recall: Z-1175-2024 · Initiated March 1, 2021

    Recall

    Recall Number
    Z-1175-2024
    Event Number
    93876
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 1, 2021
    Posted
    February 22, 2024
    Terminated
    March 6, 2025
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

    Reason

    Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.

    Action

    This is a retrospective report for the March 2021 Technical Bulletin, which described a Product Update; specifically the AIC Version 8.5 Software Update. The software update began rollout on March 4, 2021. According to the firm, Version 8.5 of the software contained bug fixes for the issues seen in version 8.4. The technical bulletin was posted to HeartRecovery.com on March 5, 2021.

    Distribution

    US Nationwide distribution.

    Quantity

    4,463 (US)