Class 1 Device Recall Venture RX Catheter,Venture OTW Catheter,Venture CS Catheter

• Date Initiated by Firm: April 25, 2017
• Date Posted: May 22, 2017
• Recall Status: Terminated on November 05, 2019
• Recall Number: Z-2224-2017
• Recall Event ID: 77202
• 510(K)Number: K040922 K042910 K061843
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: 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
• Code Information: 581713 582455 582588 583022 583409 583410 584469 584470 599777 584471 585180 585458 585459 585787 586408 586972 587035 587036 587408 587775 588097 588098 588099 588100 588794 589268 589754 589885 589886 590172 590404 590562 590776 591196 591197 591198 592080 592081 592526 592924 593080 593519 593520 593720 594204 594421 595195 595196 595418 595419 596020 597293 597294 597771 597905 597967 598903 599045 599466 599650 599903 601196 601745 601746 602260 603987 603988 603990 603991 604049 604500 604862 605617
• Recalling Firm/ Manufacturer: Vascular Solutions, Inc.; 6464 Sycamore Ct N; Maple Grove MN 55369-6032
• For Additional Information Contact: Sales Representative; 763-656-4300
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 13,551 (7,054 are unexpired)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY and Original Applicant = ST. JUDE MEDICAL; 510(K)s with Product Code = DQY and Original Applicant = VELOCIMED INC.