BEUDAMED
    FDA Enforcement Class I Completed

    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

    Recall: Z-0831-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0831-2025
    Event ID
    95991
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    Nuwellis Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    December 11, 2024
    Classification Date
    January 16, 2025
    Address
    12988 Valley View Rd, Eden Prairie, MN, 55344-3657, United States

    Description

    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

    Reason

    The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

    Code Info

    Lot Numbers: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723, 22724, 22733, 22734, 22735, 22736, 22737, 22738, 22739, 22740.

    Distribution

    US Nationwide Distribution and the country of Hong Kong

    Quantity

    845 units