BEUDAMED
    FDA Recall Terminated

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    Recall: Z-0441-2024 · Initiated October 10, 2023

    Recall

    Recall Number
    Z-0441-2024
    Event Number
    93406
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 10, 2023
    Posted
    December 1, 2023
    Terminated
    March 6, 2025
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    Reason

    Pump not detected as connected to controller due to software issue.

    Action

    An Urgent Medical Device Correction was issued vail mail October 24. 2023. Customers are advised to examine inventory for product running AIC software version: V8.4 or V8.4.1. Do not to use the product unless software is updated. Contact [email protected] to schedule the software update and return the business reply form. Forward this information to relevant personnel and any facility product may have been transferred to.

    Distribution

    US: AZ, CA, FL, NY & VA.