Events

Device Recall Medtronic Intrathecal Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Neurological 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
    35931
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1414-06
  • 사례 시작날짜
    2006-07-21
  • 사례 출판 날짜
    2006-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47187
  • 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
    Intrathecal Catheter - Product Code LKK
  • 원인
    Tip dislodgement during implantation-medtronic is recalling model 8731 intrathecal catheter and model 8598 intrathecal catheter distal revision kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
  • 조치
    An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.

Device

Device Recall Medtronic Intrathecal Catheter
  • 모델명 / 제조번호(시리얼번호)
    Model 8731 Base Lot Numbers: B011311N, B011421N, B011422N, B011500N, B011721N, B011737N, B011738N, B011786N, N0012097, N0012140, N0012141, N0012521, N0012692, N0012814, N0012815, N0012816, N0013149, N0013150, N0013352, N0013353, N0013354, N0013355, N0013707, N0013710, N0013936, N0014007, N0014236, N0014237, N0014330, N0014331, N0014332, N0014722, N0015050.   *Model 8731 Catheters and Model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom
  • 제품 설명
    Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
  • Manufacturer
    Medtronic Neurological

Manufacturer

Medtronic Neurological
  • 제조사 주소
    Medtronic Neurological, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA