BEUDAMED
    FDA Enforcement Class II Terminated

    Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.

    Recall: Z-2718-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2718-2015
    Event ID
    71881
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 22, 2015
    Classification Date
    September 2, 2015
    Termination Date
    April 28, 2016
    Address
    2870 Kilgore Rd, N/A, Rancho Cordova, CA, 95670-6133, United States

    Description

    Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.

    Reason

    Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.

    Code Info

    Product Code PPLUS20; All lots

    Distribution

    Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.

    Quantity

    5042 devices