Home / Recalls / Vascular Solutions, Inc. / Z-2224-2017

Z-2224-2017 Class I Terminated

Recalled by Vascular Solutions, Inc. — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
June 28, 2017
Initiation Date
April 25, 2017
Termination Date
November 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,551 (7,054 are unexpired)

Product 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 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.

Distribution Pattern

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.

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

Other recalls by Vascular Solutions, Inc.

  • Z-0111-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0112-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-0110-2021 Class I — Langston Dual Lumen Catheter (August 31, 2020)
  • Z-0113-2021 Class I — Langston Dual Lumen Catheter. (August 31, 2020)
  • Z-1747-2020 Class I — Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in (March 16, 2020)
  • Z-2249-2018 Class II — Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (May 4, 2018)
  • Z-2180-2017 Class II — Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. (April 12, 2017)
  • Z-1250-2017 Class II — GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Pr (January 12, 2017)
  • Z-0054-2017 Class I — Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized wi (September 16, 2016)
  • Z-0053-2017 Class I — Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. (September 16, 2016)