Events

Device Recall MobiCath BiDirectional Guiding Sheath 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Greatbatch Medical 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
    63676
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0611-2013
  • 사례 시작날짜
    2012-11-12
  • 사례 출판 날짜
    2012-12-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114516
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    Greatbatch medical observed some anomalies of the inner lumen of the mobicath bi-directional guiding sheaths upon implementation of a new visual inspection tool. the anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).
  • 조치
    Biosense Webster sent an "Urgent Field Safety Notice" dated November 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Voluntary Field Removal Certification Form was attached for customers to complete and return. Contact the firm at 800-729-9010 for questions related to this issue.

Device

Device Recall MobiCath BiDirectional Guiding Sheath
  • 모델명 / 제조번호(시리얼번호)
    LOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of AL, AK, AZ, ALR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KY, MD, MA, MI, MN, MO, NE, NV,NM, NJ, NH, NY, NC, OH, OK OR, PA, RI,SC,SD, TN, TX, UT,VT, VA, WA, and WI, and the countries of AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HUNGARY, IRELAND, ISRAEL, ITALY, THE NETHERLAND, NORWAY, SWEDEN, AUSTRALIA, and CANADA
  • 제품 설명
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. || The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • 제조사 주소
    Greatbatch Medical, 2300 Berkshire Ln N, Minneapolis MN 55441-4575
  • 제조사 모회사 (2017)
    Integer Holdings Corporation
  • Source
    USFDA