Events

Device Recall Boston Scientific Fetch 2 Aspiration Catheter 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
    73633
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1342-2016
  • 사례 시작날짜
    2016-03-22
  • 사례 출판 날짜
    2016-04-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144639
  • 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, embolectomy - Product Code DXE
  • 원인
    Boston scientific is recalling all models of fetch 2 aspiration catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.Cdrh.Fda.Gov/division-tracking/images/trash.Pngbroken shaft from the patient.
  • 조치
    The firm,Boston Scientific, "Urgent Medical Device Recall Notice - Immediate Action Required" letter dated 3/22/2016. The letter was addressed to Material Manger / Field Action Contact. The letter described the problem and the product involved in the recall and actions to be taken. The customers were instructed to immediately cease further distribution or use of the product and complete and return the Reply Verification Tracking Form via email: BSCFieldActionCenter@bsci.com or fax to: BSC Field Action Center at 1-866-213-1806. Distributors should notify their customers of the recall and inform them that this recall is to the hospital level. For questions regarding this communication, please contact your local Boston Scientific Sales Representative or the Boston Scientific Field Action Center at 763-494-1133 or email: BSCFieldActionCenter@bsci.com.

Device

Device Recall Boston Scientific Fetch 2 Aspiration Catheter
  • 모델명 / 제조번호(시리얼번호)
    BATCH 129496 130473 139577 141089 141570 142212 145520 145783 148859 149263 153368 153847 154650 154786 155675 155908 156690 156822 158009 158494 158598 159368 159902 160530 161209 162814 162893 162943 163987 164148 166281 166646 168472 169484 169638 170169 170464 170471 171178 171385 171800 172254 172375 172518 172831 173151 173398 173897 173902 174153 174431 174617 174619 174721 174722 174727 174728 174804 174805 175189 175190 175782 175783 176048 176221 176385 176437 176438 176843 177414 177415 177970 177971 178252 178253 178254 178764 178848 178849 178894 178935 178936 180305 180306 180367 180368 180370 180747 181168 181169 181285 181933 181934 182257 182258 182259 182927 183220 183221 183451 183452 183539 183540 183974 184091 184092 184093 184244 184245 184478 184479 184531 184532 184633 184634 185180 185182 185354 185355 185395 185396 185397 185632 185633 185958 185959 185960 186145 186146 186147 186148 186149 186150 186151 186152 186153 186154 186326 186338 186498 186553 186554 186555 186556 186557 186558 186559 186732 186733 186765 186766 186767 186768 186769 186839 186876 186877 186938 186939 186940 187157 187158 187238 187239 187778 187779 187811 187812 188206 188207 188208 188758 188759 189082 189230 189231 189232 189233 189234 189235 189236 189237 189238 189239 189240 189241 189242 189243 189244 189245 189273 189274 189374 191401 191402 191403 191404 191405 191406 191407 191408 191409 191802 191803 192256 192257 192355 192356 192466 192467 192468 192469 192470 192471 192483 192484 192485 192486 192777 192778 192779 192780 192784 192785 192786 192914 192915 192916 192917 192918 192919 192921 192922 192923 192925 192926 192927 192928 192929 192930 192931 192932 192933 193146 193147 193148 193149 193150 193151 193152 193153 193154 193155 193156 193158 193159 193160 193161 193162 193356 193357 193358 193360 193361 193362 193363 193364 193449 193450 193451 193952 193953 193954 193955 193956 193957 193958 193959 193960 193961 193962 193963 193964 193965 193966 193967 193968 193969 193970 18737680 18760027 18760028 18844376 18881248 18939879 154901 155010 158949 160734 161256 172256 174316 174358 174381 174382 174383 176146 176324 176441 176442 176473 180748 180841 180842 180843 181497 181498 182438 182439 182923 182925 183830 183977 183978 185398 185644 186329 186330 186331 186332 186333 186334 186335 189612 189613 192478 192479 192480 192481 192482 193972 171807 171869 174834 178152 180301 181688 185645 186327 187539 190073 193444 176327 186144 186328 186734 188803 188804 188805 188806 188807 188808 188809 188810 188811 188812 188813 188814 188815 188816 188817 187150 187505 187509 187510 190463 190464 190465 190466 190982 190983 190984 192781 192782 192783 193447 193973 194039
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including DC & VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.
  • 제품 설명
    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. || Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 2 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