BEUDAMED
    FDA Recall Terminated

    Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar.

    Recall: Z-2053-2009 · Initiated March 16, 2009

    Recall

    Recall Number
    Z-2053-2009
    Event Number
    51674
    Firm
    Integra Neuro Sciences
    FEI Number
    2023988
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 16, 2009
    Posted
    September 8, 2009
    Terminated
    July 19, 2012
    Address
    5955 Pacific Center Blvd, San Diego, CA, 92121

    Description

    Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar.

    Reason

    Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.

    Action

    An "Urgent-Product Recall Notification" letter dated March 23, 2009 was issued to consignees. The letter described the issue and instructed customers to examine their inventory immediately to determine whether they have any NL950V - Ventrix Ventricular Tunneling Pressure Monitoring Kits, or NL950VC - Ventrix Ventricular Tunneling Pressure Monitoring Kits with Ventricular Drainage System. Customers were further instructed not to use the above recalled product. Call Integra Customer Service at 1-800-654-2873, and then select 5 for 'Returns and Repairs' to obtain a Returned Material Authorization number, and return the product as directed. Direct questions about the recall to Integra NeuroSciences by calling 1-858-455-1115, extension185.

    Distribution

    Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.

    Quantity

    274 kits