Events

Device Recall Neuroform 3 Microdelivery Stent System 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
    55760
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0482-2011
  • 사례 시작날짜
    2010-03-01
  • 사례 출판 날짜
    2010-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91735
  • 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
    Intracranial neurovascular stent - Product Code NJE
  • 원인
    The product may contain manufacturing aids (mandrels) which should not be present in the final product. if the mandrel remains in place, the catheter cannot be loaded over the required guidewire, so cannot be used.
  • 조치
    Boston Scientific issued an Urgent Customer Notice dated March 1, 2010 to all US customers, with personal delivery by sales representative where applicable outside the US, identifying the affected device. Customers were instructed to return the device for replacement, and to return an acknowledgement form. Customers can contact Deborah Springer at Boston Scientific at 800-845-4598 about this recall.

Device

Device Recall Neuroform 3 Microdelivery Stent System
  • 모델명 / 제조번호(시리얼번호)
    Model number: M003E3400300; expiration date October 2012   UPN Batch UPN Batch  M003E3300150 12907487 M003E3400150 12954887 M003E3300200 12915007 M003E3400200 12954888 M003E3350200 12915008 M003E3400300 12958309 M003E3450200 12915009 M003SNF330200 12965212 M003SNF330200 12915010 M003SNF335200 12965215 M003SNF340200 12915011 M003SNF335300 12968779 M003SNF345200 12915013 M003SNF335200 12969012 M003E3300300 12922996 M003SNF345300 12969013 M003E3350200 12923544 M003E3450150 12973549 M003E3300200 12925243 M003E3300200 12976185 M003E3400200 12925245 M003E3350300 12976374 M003E3400300 12925248 M003E3450200 12976378 M003E3450300 12925252 M003SNF330200 12978991 M003SNF325200 12929490 M003SNF335200 12969012 M003SNF30150 12929491 M003SNF340200 12979305 M003SNF335200 12929492 M003E3300200 12983886 M003SNF340200 12929494 M003SNF345300 12982462 M003SNF330150 12929491 M003E3400150 12990085 M003SNF345200 12929492 M003E3400200 12990088 M003SNF340200 12929494 M003E34000300 12990098 M003SNF340300 12929495 M003E3450200 12990124 M003SNF325200 12932459 M003SNF330200 12993187 M003SNF345200 12932945 M003SNF335150 12993189 M003SNF345300 12932946 M003SNF340200 12993190 M003E3350200 12936662 M003SNF340300 12993193 M003E3400200 12936665 M003E3350200 12996254 M003E3450150 12936668 M003SNF34150 12996255 M003E3450200 12940485 M003SNF335200 12996436 M003E3450300 12940950 M003E3400150 13010766 M003SNF335150 12943248 M003E3450300 13010770 M003SNF335200 12943594 M003SNF325200 13010771 M003SNF340200 12943598 M003SNF330150 13010772 M003E3250200 12947325 M003E3350200 13013322 M003E3300200 12947486 M003E3350300 13013323 M003E3450300 12947611 M003SNF335200 13017103 M003E3350200 12950991 M003SNF335200 12969012 M003SNF325150 12950988 M003SNF345300 12950989
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    HDE
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: Throughout the US and to the countries of: Austria, Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Germany, Denmark, Ecuador, Spain, France, Great Britain, Greece, Hungary, India, Ireland, Italy, South Korea, Luxemburg, Mexico, the Netherlands, New Zealand, Peru, Russian Federation, Sweden, Slovenia, Taiwan and Ukraine.
  • 제품 설명
    Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 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