BEUDAMED
    FDA Recall Open, Classified

    NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

    Recall: Z-1309-2024 · Initiated October 11, 2023

    Recall

    Recall Number
    Z-1309-2024
    Event Number
    94016
    FEI Number
    3011468686
    Product Code
    BYS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 11, 2023
    Posted
    March 19, 2024
    Address
    2555 Bishop Cir W, Inc Mc3, Dexter, MI, 48130-1563

    Description

    NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

    Reason

    May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

    Action

    Medtronic (MC3's global distributor)issued issued Urgent Customer Notification letter to end-users on 11/26/24. Letter states reason for recall, health risk and action to take: " During the priming procedure, users may check water flow through the oxygenator water path prior to use. " Patient core body temperature must be monitored routinely during ECMO. Customer Actions: Medtronic records indicate that your facility has received at least one of the impacted serial numbers. As a result, Medtronic requests that you take the following actions: " Complete the enclosed Customer Confirmation Form, acknowledging that you have received this information, and email to [email protected] " This notice must be passed on to all who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative

    Distribution

    US Nationwide distribution.

    Quantity

    299 units