Events

VIA 27 Microcatheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sequent Medical 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
    75211
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0114-2017
  • 사례 출판 날짜
    2016-10-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149671
  • 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, continuous flush - Product Code KRA
  • 원인
    Sequent medical is recalling the via 27 microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.
  • 조치
    Sequent Medical sent an Urgent Medical Device Recall letter dated September 23, 2016, to all affected customers. The letter informed customers that Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The letter informs the customers of the risk to health and actions to be taken. Customers were instructed to send all confirmation forms and questions to www.customerserviceus@sequentmedical.com. Customers with questions should call (949) 830-9600x130. For questions regarding this recall call 949-923-9400.

Device

VIA 27 Microcatheters
  • 모델명 / 제조번호(시리얼번호)
    16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,
  • 제품 설명
    VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 || The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
  • Manufacturer
    Sequent Medical Inc

Manufacturer

Sequent Medical Inc
  • 제조사 주소
    Sequent Medical Inc, 11 Columbia, Aliso Viejo CA 92656-1460
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA