Events

Device Recall XSizer Thrombectomy Catheter System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ev3, Inc 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
    34708
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1107-06
  • 사례 시작날짜
    2006-02-14
  • 사례 출판 날짜
    2006-06-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44517
  • 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
    Thrombectomy Catheter System - Product Code MCW
  • 원인
    Loss of operating vacuum during use-it has been determined that a small percentage of x-sizer thrombectomy catheter systems from specific lots may lose operating vacuum prematurely due to a system leak within the control module. this failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
  • 조치
    A medical Device Recall Letter dated 02/13/06 was sent to hospitals along the affected device lot numbers the hospital should have received on a Device Reconciliation Form. ev3 is asking for affected devices to be returned. Returned devices will be replaced at no cost.

Device

Device Recall XSizer Thrombectomy Catheter System
  • 모델명 / 제조번호(시리얼번호)
    Model number XD-CS1150-45 (for US distribution), lot numbers: 782344, 782345, 782366, 782379, 782386, 782389,  782403, 782404, 782406, 782407, 782412, 782421, 782428,  782429, 782430, 782436, 782438, 782439, 782441, 782445,  782526, 986604, 986604, 986604, 986605, 986609, 986620,  986626, 986640, 986641, 986642, 986645, 986656, 986659,  1174394, 1174395, 1212529, 1229730, 1231296, 1234273,  1240986, 1241067, 1271238, 1272506, 1280664, 1280952,  1281088, 1282693, 1289590, 1289978, 1293902, 1295372,  1300605, 1302005, 1303572, 1308536, 1310238, 1362165.   Model number XR-CS1150-45 (for OUS distribution), lot numbers: 782773, 782777, 782787, 782788, 782790, 782791,  782795, 782796, 782797, 782798, 782800, 782801, 782804,  782808, 782811, 782812, 782816, 782818, 782822, 782848,  987054, 987055, 987056, 987058, 987059, 987062, 987063,  987064, 987065, 987066, 987067, 987070, 987070, 987070,  987071, 987073, 987076, 987078, 1057871, 1077841, 1077842, 1077843, 1077844, 1077846, 1077847, 1077848,  1077854, 1077856, 1077859, 1077862, 1095087, 1095089,  1296437, 1296552, 1313297, 1313502, 1313543, 1313562,  1313611, 1313645, 1314989, 1314991, 1314994, 1315002, 1315042, 1315058, 1315113, 1315140, 1315183, 1315211,  1315245, 1315292, 1315294, 1315313, 1315328, 1315365,  1315378, 1315383, 1315623, 1315624, 1315625, 1315626,  1315632, 1315633, 1315636, 1315639, 1315640, 1315644,  1315646, 1317128, 1317133, 1317134, 1317135, 1317144,  1317301, 1326969, 1326969, 1326969, 1326970, 1326972,  1326973, 1326974, 1326977, 1326982, 1326983, 1326998,  1326999, 1327006, 1327008, 1327011, 1327546, 1342794,  1342852, 1342874, 1342882, 1342888, 1342957, 1342980,  1343007, 1343019, 1343036, 1343045, 1343094, 1343108,  1343125, 1343136, 1343266, 1343273, 1343292, 1343314,  1363701, 1363712, 1363725, 1363742, 1363791, 1363827,  1363850, 1363974, 1363976, 1364006, 1364034, 1364049.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    World wide-AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. OUS to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Jordan, Mexico, Netherlands, Norway, Pakistan, Portugal, Saudi Arabi, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
  • 제품 설명
    X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA.
  • Manufacturer
    Ev3, Inc

Manufacturer

Ev3, Inc
  • 제조사 주소
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA