Events

Device Recall Archer Super Stiff Guidewire 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Disease Management 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
    64620
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1017-2013
  • 사례 시작날짜
    2013-03-13
  • 사례 출판 날짜
    2013-03-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116638
  • 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
    Wire, guide, catheter - Product Code DQX
  • 원인
    Medtronic has identified an issue with a specific lot of the archer 0.035 inch (0.89mm) super stiff guidewire, model arcsj200w, where the ptfe (teflon) coating has the potential to separate from the wire during in-vivo use.
  • 조치
    Medtronic sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Medtronic requested any unused guidewires from the lot number to be quarantined, and returned by contacting the customer service phone number at 1-888-283-7868. A Customer Confirmation Certificate was requested to be faxed back to Medtronic at 651-367-0612.

Device

Device Recall Archer Super Stiff Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Lot number GFWA0387
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
  • 제품 설명
    Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. || Intended to facilitate catheter placement and exchange during procedures in the aorta.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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