BEUDAMED
    FDA Enforcement Class I Ongoing

    Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

    Recall: Z-1760-2025 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1760-2025
    Event ID
    96697
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Centerline Biomedical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 28, 2025
    Initiation Date
    April 11, 2025
    Classification Date
    May 19, 2025
    Address
    10000 Cedar Ave, N/A, Cleveland, OH, 44106-2119, United States

    Description

    Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

    Reason

    Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

    Code Info

    UDI/DI 00843152102037, Lot Number 2404-2005

    Distribution

    US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee

    Quantity

    80 units