BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 11, 2025

    Recall

    Recall Number
    Z-1760-2025
    Event Number
    96697
    Firm
    Centerline Biomedical Inc
    FEI Number
    3012154226
    Product Code
    DQK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 11, 2025
    Posted
    May 19, 2025
    Address
    10000 Cedar Ave, Cleveland, OH, 44106-2119

    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.

    Action

    Centerline Biomedical issued an "URGENT MEDICAL DEVICE RECALL" notice dated 4/11/2025 to its consignees on 04/11/2025 via hand delivery. The notice explained the issue with the device, potential risk to the patient and actions to be taken. The consignees were requested to Complete the Customer Acknowledgement letter in the possession of your Clinical Account Manager and return all affected products to Clinical Account Manager. For questions contact: Director Quality and Regulatory, Phone Number: (330) 577-5033, Email: [email protected].

    Distribution

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

    Quantity

    80 units