Events

UltraFlow HPC Flow Directed Micro Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Micro Therapeutics Inc, Dba Ev3 Neurovascular 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
    63188
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2471-2012
  • 사례 시작날짜
    2011-09-23
  • 사례 출판 날짜
    2012-09-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112878
  • 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
    The recall was initiated because ev3 neurovascular has identified one lot of ultraflow flow directed micro catheters and marathon flow directed micro catheters may have been mislabeled.
  • 조치
    Micro Therapeutics Inc, Dba Ev3 Neurovascular sent a recall notification letter dated September 23, 2011 to all their affected customers. The letter identified the affected product, problem, and actions to be taken. The notification letter also provides the customer (physician) with appropriate information regarding the affected products. The letter instructs customer to stop using the affected product, segregate from inventory and return for replacement with conforming product. The notice requests the customer to complete and return the reply form indicating use or return of devices in the affected lot(s). Customers with questions regarding the recall letter were instructed to contact Kim Salceda at (949) 680-1305.

Device

UltraFlow HPC Flow Directed Micro Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot # 9374298
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
  • 제품 설명
    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. || Product Usage: || The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
  • Manufacturer
    Micro Therapeutics Inc, Dba Ev3 Neurovascular

Manufacturer

Micro Therapeutics Inc, Dba Ev3 Neurovascular
  • 제조사 주소
    Micro Therapeutics Inc, Dba Ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA