Events

Device Recall Renegade Hi Flo Microcatheter 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
    53143
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2245-2009
  • 사례 시작날짜
    2009-08-26
  • 사례 출판 날짜
    2009-09-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84862
  • 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
    Continuous Flush Catheter - Product Code KRA
  • 원인
    Boston scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. it has been reported that the pouch seal (top seal) may be breached.
  • 조치
    Consignees were sent a Boston Scientific Urgent Medical Device Recall Removal - Immediate Action Required letter Dated August 26,2009. The letter was addressed to Risk Manager / Field Action Contact. The letter described the problem and product involved. Advised consignees to segregate the affected product and return it to Boston Scientific. Requested the return and completion of The Account Reply Verification Tracking form enclosed. Replacements will be issued for all recalled product that is properly returned to Boston Scientific.

Device

Device Recall Renegade Hi Flo Microcatheter
  • 모델명 / 제조번호(시리얼번호)
    Material Batch # M001182570 11253574 M001182570 11268801 M001182570 11296064 M001182570 11301389 M001182570 11307943 M001182570 11429069 M001182570 11432584 M001182570 11444027 M001182570 11461698 M001182570 11481564 M001182570 11542408 M001182570 11552115 M001182570 11559603 M001182570 11572313 M001182570 11577242 M001182570 11586443 M001182570 11587960 M001182570 11631734 M001182570 11656601 M001182570 11678955 M001182570 11682874 M001182570 11710717 M001182570 11750295 M001182570 11756331 M001182570 11793108 M001182570 11819657 M001182570 11825864 M001182570 11836834 M001182570 11849818 M001182570 11878193 M001182570 11880345 M001182570 11891449 M001182570 11895180 M001182570 11927490 M001182570 11941913 M001182570 11959863 M001182570 11966695 M001182570 12021328 M001182570 12049925 M001182570 12061129 M001182570 12089556 M001182570 12120528 M001182570 12133525 M001182570 12142150 M001182570 12156146 M001182570 12175708 M001182570 12194075 M001182570 12214586 M001182570 12214589 M001182570 12214602 M001182570 12228116 M001182570 12228366 M001182570 12228393 M001182570 12248055 M001182570 12248121 M001182570 12270709 M001182570 12270714 M001182570 12279662 M001182570 12296121 M001182570 12296833 M001182570 12311446 M001182570 12311459 M001182570 12330440 M001182570 12330443 M001182570 12330476 M001182570 12348609 M001182570 12365495 M001182570 12365604 M001182570 12365613 M001182570 12385143 M001182570 12385224 M001182570 12402095 M001182570 12421265 M001182570 12421271 M001182570 12439946 M001182570 12439951 M001182570 12439958 M001182570 12458475 M001182570 12458543 M001182570 12466721 M001182570 12509758 M001182570 12527760 M001182570 12527769 M001182570 12546941 M001182570 12560791 M001182570 12578835 M001182570 12578864 M001182570 12614498 M001182570 12634309 M001182570 12634315 M001182570 12660000 M001182590 11249879 M001182590 11257185 M001182590 11271408 M001182590 11274973 M001182590 11303513 M001182590 11318319 M001182590 11319596 M001182590 11423369 M001182590 11425310 M001182590 11425314 M001182590 11429065 M001182590 11432583 M001182590 11441965 M001182590 11445708 M001182590 11469070 M001182590 11534917 M001182590 11546053 M001182590 11554501 M001182590 11562655 M001182590 11573780 M001182590 11580376 M001182590 11602048 M001182590 11623809 M001182590 11627605 M001182590 11638177 M001182590 11649446 M001182590 11695922 M001182590 11703970 M001182590 11706368 M001182590 11714291 M001182590 11721375 M001182590 11776786 M001182590 11800162 M001182590 11806766 M001182590 11840079 M001182590 11843094 M001182590 11857667 M001182590 11869009 M001182590 11884227 M001182590 11891458 M001182590 11895183 M001182590 11925162 M001182590 11933896 M001182590 11948975 M001182590 11988066 M001182590 11996448 M001182590 12028753 M001182590 12039033 M001182590 12068930 M001182590 12073676 M001182590 12104631 M001182590 12108064 M001182590 12120518 M001182590 12142142 M001182590 12156183 M001182590 12175724 M001182590 12194829 M001182590 12214604 M001182590 12248109 M001182590 12262088 M001182590 12270983 M001182590 12297455 M001182590 12311520 M001182590 12326062 M001182590 12330441 M001182590 12330465 M001182590 12365497 M001182590 12365605 M001182590 12365614 M001182590 12385142 M001182590 12385158 M001182590 12402111 M001182590 12421267 M001182590 12421274 M001182590 12439954 M001182590 12458474 M001182590 12458476 M001182590 12458546 M001182590 12466723 M001182590 12491154 M001182590 12509751 M001182590 12509920 M001182590 12527317 M001182590 12527763 M001182590 12546795 M001182590 12546799 M001182590 12546946 M001182590 12560792 M001182590 12578834 M001182590 12634310 M001182590 12659579 M003182880US0 12001306 M003182880US0 12001306 M003182880US0 12104678 M003182880US0 12123141 M003182880US0 12148684 M003182880US0 12148687 M003182880US0 12170507 M003182880US0 12170508 M003182880US0 12170516 M003182880US0 12175711 M003182880US0 12175713 M003182880US0 12175719 M003182880US0 12194077 M003182880US0 12194831 M003182880US0 12214616 M003182880US0 12228443 M003182880US0 12292373 M003182880US0 12330511 M003182890US0 12001562 M003182890US0 12001562 M003182890US0 12148683 M003182890US0 12175706 M003182900US0 12001567 M003182900US0 12001567 M003182900US0 12156147 M003182900US0 12175704 M003182900US0 12175710 M003182900US0 12175717 M003182900US0 12214592 M003182900US0 12228444 M003182910US0 12001568, and M003182910US0 12001568.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, excluding New Mexico and Wyoming, and countries of Europe, the Middle East and Africa, Japan, American Virgin Islands, Argentina, Aruba, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dutch Antilles, Egypt, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Libya, Luxembourg, Macau, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Romania, Saudia Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, and Vietnam.
  • 제품 설명
    Boston Scientific Renegade" Hi Flo Microcatheter (neurovascular use) REF 18-288OUS, Sterilized using ethylene oxide, Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA || Made in Ireland, Business & Technology Park, Model Farm Road, Cork, Ireland. || Material Catalog # Description || M001182570 18257 Renegade" 18 150/10 (2-tip marker) || M001182590 18259 Renegade" 18 150/20 (2-tip marker) || M003182880US0 182880US Neuro Renegade" Hi Flo" 135/10 || M003182890US0 182890US Neuro Renegade" Hi Flo" 135/20 || M003182900US0 182900US Neuro Renegade" Hi Flo" 150/10 || M003182910US0 182910US Neuro Renegade" Hi Flo" 150/20
  • 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