Events

Device Recall Boston Scientific Fort 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
    52098
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1486-2009
  • 사례 시작날짜
    2009-05-12
  • 사례 출판 날짜
    2009-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82090
  • 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
    intravascular guide wire - Product Code DQX
  • 원인
    Product packaged incorrectly. one batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the.
  • 조치
    Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated may 19, 2009. The letter was addressed to "Dear Risk Manger/ Field Action Contact". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form.

Device

Device Recall Boston Scientific Fort
  • 모델명 / 제조번호(시리얼번호)
    W2405148
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA distribution: AR, MO, CA, FL, and NV.
  • 제품 설명
    Boston Scientific Fort¿¿ Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
  • 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