Events

Venture RX Catheter,Venture OTW Catheter,Venture CS Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vascular Solutions, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    77202
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2224-2017
  • 사례 시작날짜
    2017-04-25
  • 사례 출판 날짜
    2017-05-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155426
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, percutaneous - Product Code DQY
  • 원인
    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.
  • 조치
    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.

Device

Venture RX Catheter,Venture OTW Catheter,Venture CS Catheter
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • 제조사 주소
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA