BEUDAMED
    FDA Recall Terminated

    Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents

    Recall: Z-2224-2017 · Initiated April 25, 2017

    Recall

    Recall Number
    Z-2224-2017
    Event Number
    77202
    Firm
    Vascular Solutions, Inc.
    FEI Number
    3002827704
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 25, 2017
    Posted
    May 22, 2017
    Terminated
    November 5, 2019
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032

    Description

    Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents

    Reason

    Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.

    Action

    The firm, Vascular Solutions, sent an "URGENT: Medical Device Recall" letter dated April 25, 2017, to all affected consignees. The letter described the problem and the product involved in the recall and actions to be taken. Consignees were instructed to identify location of all unused product in your possession; immediately cease further use or distribution, remove any unused product , place it in a secure area, and complete and return the VSI Account Inventory Form by email to: customerservice@vascom or fax to (763)656-4251. VSI Customer Service Department will contact consignees for return authorization of the product. If you have any specific questions or concerns regarding this matter, please contact your local sales representative or call 763-656-4300.

    Distribution

    Worldwide Distribution - US (nationwide): including states of: AK, AL, AR, AZ, CA, CO, CT, DC,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, ME, MI, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY,and UK.

    Quantity

    13,551 (7,054 are unexpired)