Events

Micrus Endovascular Microcoil Delivery System; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 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
    57192
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0845-2011
  • 사례 시작날짜
    2010-10-21
  • 사례 출판 날짜
    2011-01-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95562
  • 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
    Device, neurovascular embolization - Product Code HCG
  • 원인
    The firm has received reports of difficulty connecting to the detachment control cable. loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.
  • 조치
    Micrus Endovascular Corp sent Urgent: Medical Device Recall Letters dated October 21, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine inventory (including consignment) and quarantine the product to prevent it from being used or shipped. If the product was further distributed, customers were to notify their customers by sending a copy of the recall letter and were instructed to work with all customers to ensure that all product was returned and that pre-use protocol was followed. The response form was to be completed and returned indicating the number of devices that had been used (or shipped if distributor) and the number that would be returned. Customers were to call the Micrus Customer Service Department at 1-888-550-4129 from 8:00 am to 5:00 Pacific time for arrange for a Return Authorization number and replacement. Recall letters also stressed the importance of always following the pre-use protocol and inspecting the device immediately prior to use. Additionally, connector functionality should be verified and instructions were provided. Questions or concerns should be directed to Micrus Customer Service at 1-888-4120. Consignees who did not respond to the initial recall notification after 15 days were notified again by letter. A third letter was sent after another 15 days if there was still no response.

Device

Micrus Endovascular Microcoil Delivery System;
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: F62328 ,G11073 ,G11135 ,G11205 ,G11271 ,G11368  ,F62370 ,G11074 ,G11138 ,G11208 ,G11273 ,G11370  ,G10831 ,G11075 ,G11139 ,G11209 ,G11274 ,G11371  ,G10874 ,G11076 ,G11140 ,G11210 ,G11275 ,G11374  ,G10889 ,G11079 ,G11144 ,G11211 ,G11276 ,G11376  ,G10915 ,G11081 ,G11146 ,G11212 ,G11279 ,G11379  ,G10928 ,G11082 ,G11147 ,G11213 ,G11280 ,G11381  ,G10939 ,G11084 ,G11149 ,G11214 ,G11281 ,G11385  ,G10940 ,G11086 ,G11151 ,G11216 ,G11283 ,G11386  ,G10949 ,G11087 ,G11152 ,G11217 ,G11284 ,G11567  ,G10951 ,G11088 ,G11153 ,G11218 ,G11285 ,G11604  ,G10953 ,G11090 ,G11154 ,G11219 ,G11287 ,G11698  ,G10962 ,G11093 ,G11155 ,G11223 ,G11289 ,G11741  ,G10965 ,G11094 ,G11157 ,G11224 ,G11293 J10184  ,G10967 ,G11095 ,G11165 ,G11225 ,G11294 J10185  ,G10969 ,G11098 ,G11166 ,G11228 ,G11295 J10186  ,G10971 ,G11100 ,G11171 ,G11229 ,G11297 J10187  ,G10987 ,G11101 ,G11172 ,G11230 ,G11298 J10188  ,G10995 ,G11102 ,G11173 ,G11233 ,G11303 J10189  ,G10996 ,G11106 ,G11175 ,G11235 ,G11304 J10190  ,G10997 ,G11109 ,G11176 ,G11238 ,G11307 J10191  ,G11007 ,G11111 ,G11177 ,G11239 ,G11310 J10192  ,G11009 ,G11112 ,G11180 ,G11242 ,G11314 J10193  ,G11010 ,G11114 ,G11182 ,G11244 ,G11315 J10194  ,G11025 ,G11115 ,G11184 ,G11246 ,G11316 J10195  ,G11027 ,G11117 ,G11185 ,G11249 ,G11318 J10196  ,G11032 ,G11118 ,G11186 ,G11251 ,G11325 J10219  ,G11034 ,G11121 ,G11187 ,G11253 ,G11326 ,G10946  ,G11044 ,G11122 ,G11191 ,G11256 ,G11327 ,G11062  ,G11050 ,G11126 ,G11192 ,G11258 ,G11328 ,G11369  ,G11053 ,G11127 ,G11193 ,G11262 ,G11332  ,G11054 ,G11128 ,G11194 ,G11263 ,G11333  ,G11055 ,G11129 ,G11195 ,G11265 ,G11335  ,G11065 ,G11131 ,G11198 ,G11268 ,G11350  ,G11068 ,G11132 ,G11199 ,G11269 ,G11356  ,G11071 ,G11133 ,G11200 ,G11270 ,G11364
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including AK, AL, AZ, CA, CO, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Republic of Korea, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom
  • 제품 설명
    Micrus Endovascular Microcoil Delivery System; || The Micrus¿ Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. || Catalog Numbers: || PC4180933, SSR181128, CPL100252, || PC4181647, SSR181640, CPL100404, || DFS100254, SSR181230, CPL100406, || DFS100410, DPL100206, SRC141230, || CRC140304, DFS100716, CRC140406, || CPL100203, DFS100204, DPL100408, || SSR100253, PC4181240, DPL100202, || CDF100408, PC4181137, CSP100500, || CDF100154, PC4180830, CSP100350, || DFS100152, SRC140408, PC4181034, || CPL100206, CDF100152, SRC141025, || SRC140225, CPL100304, CRC141025, || CPL 100254, PC4181447, DPL100252, || DFS100154, SRC140303, DFS100720, || DPL 100204, PC4181343, CSP180500, || DFS1 0031 0, DPL100306, DPL100256, || CPL100306, CDF100304, CDF100203, || CDF100410, PC4100412, DPL 100254, || DPL 100053, PC41 00626, CDF100208, || CRC140306, PC4100517, DFS100203, || CSP181400, CPL 100152, DFS100210, || CDF100720, CPL100204, CSP180200, || DFS100204, CDF100510, DFS101025, || DFS100408, PC41 00730, SSR181740, || CRC140615, CPL100256, CDF100206, || DFS100308, CPL100151, CSP100200, || CDF100616, CRC140711, SSR181334, || CDF100310, SRC140445, DFS100252, || CPL100408, CDF100306, DFS100250, || DPL 100152, DPL 100201, CDF100258, || SRC140306, CDF100156, DPL 100153, || DPL100304, SRC140922, SSR100825, || DFS100206, DPL 100203, PC4181550, || DFS100616, CSP180900, PC4181950, || DFS100406, SRC140717, PC4181750, || DFS100925, CSP100400, PC4181846, || SRC140711, CPL100153, PC4182050, || DFS100306, SRC140406, CSP100900, || SRC140615, CDF100308, CSP100300, || DFS1 0051 0, CDF100406, CDF1 0021 0, || DFS100156, CDF100515, || DPL100151, CDF100925, || SSR181028, CDF101025, || SSR181540, CPL 100201, || SSR180825, CPL 100202; || Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA
  • Manufacturer
    Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131

Manufacturer

Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131
  • 제조사 주소
    Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131, 821 Fox Ln, San Jose CA 95131-1601
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA