Events

Liberte Monorail and OvertheWire Coronary Stent Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation 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
    53435
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0068-2010
  • 사례 시작날짜
    2009-09-11
  • 사례 출판 날짜
    2009-10-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85496
  • 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
    Stent, coronary - Product Code MAF
  • 원인
    Boston scientific initiated a field correction for the liberte¿ bare-metal coronary stent products. they have received reports from cardiac cath labs that taxus liberte paclitaxel-eluting (taxus¿ libert¿¿ drug-eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a liberte¿ bare-metal stent, and libert¿¿ bare-metal stents have been ina.
  • 조치
    Boston Scientific issued an "Urgent Medical Device Field Correction" letter dated September 18, 2009. The letter was addressed to Risk Manger/Field Action Contact. The letter described the product, problem and actions which included renaming the Liberte¿¿ Bare-Metal stent as VeriFlex" Bare-Metal stent. Enclosed with the letter included the Direction for Field Correction and a Reply Verification Tracking Form. For further information, contact you local Boston Scientific Sales Representative or call 1-800-811-3211.

Device

Liberte Monorail and OvertheWire Coronary Stent Systems
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- United States including Puerto Rico.
  • 제품 설명
    Boston Scientific Liberte¿¿ Monorail¿ and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". || The Liberte¿¿ Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte¿ Monorail¿ (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte¿ system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA