BEUDAMED
    FDA Enforcement Class III Ongoing

    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

    Recall: Z-1301-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1301-2022
    Event ID
    90252
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Volcano Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2022
    Initiation Date
    May 13, 2022
    Classification Date
    June 29, 2022
    Address
    3721 Valley Centre Dr Ste 500, San Diego, CA, 92130-3328, United States

    Description

    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

    Reason

    Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

    Code Info

    All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.

    Quantity

    14.031 units