Events

Device Recall ViperWire Advance Peripheral Guide Wire with Flex Tip 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiovascular Systems 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
    76784
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1771-2017
  • 사례 시작날짜
    2017-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154177
  • 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, peripheral, atherectomy - Product Code MCW
  • 원인
    Cardiovascular systems, inc. is recalling one lot of viperwire advance with flextip, model vpr-gw-ft18 because it may contain a 0.014" viperwire advance flextip product instead of the 0.018" viperwire advance with flextip.
  • 조치
    Customers were sent an Urgent Medical Device Recall letter beginning March 03, 2017. The letter identified affected product, reason for recall, and asked for affected devices to be removed from use and return to CSI. Questions can be directed to CSI Customer Service at 877-274-0901, or your CSI Sales Representative.

Device

Device Recall ViperWire Advance Peripheral Guide Wire with Flex Tip
  • 모델명 / 제조번호(시리얼번호)
    Lot 156032
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
  • 제품 설명
    ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. || The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
  • Manufacturer
    Cardiovascular Systems Inc

Manufacturer

Cardiovascular Systems Inc
  • 제조사 주소
    Cardiovascular Systems Inc, 1225 Old Highway 8 NW, Saint Paul MN 55112-6416
  • 제조사 모회사 (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA