Events

Device Recall Strata II / Strata NSC valves 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Neurosurgery 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
    76249
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1121-2017
  • 사례 시작날짜
    2017-01-17
  • 사례 출판 날짜
    2017-02-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152582
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • 원인
    Medtronic neurosurgery initiated a recall after receiving five (5) product experiences between february 15, 2015 and august 23, 2016 reporting of discrepancies between the pressure/performance level (pl) at which the valve was set and the readings determined via an x-ray image.
  • 조치
    Medtronic sent an Urgent Product Advisory Notice dated January 19, 2017, was sent to customers to inform them that Medtronic Neurosurgery is initiating a voluntary field corrective action (FCA) for the Medtronic Strata II / Strata NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR). Medtronic is notifying healthcare providers of an Instructions For Use (IFU) Warning update for the affected products by sending a Product Advisory Notice. For further questions regarding this recall please call (805) 571-8400..

Device

Device Recall Strata II / Strata NSC valves
  • 모델명 / 제조번호(시리얼번호)
    All Lot Numbers
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Federation Bosnia and Herzegovina Japan Saudi Arabia Botswana Jordan Singapore Bulgaria Kazakhstan Slovakia Cambodia Kenya South Africa Canada Kuwait South Korea Canary Islands Latvia Spain Cayman Islands Lebanon Sri Lanka China Libya Sweden Croatia Lithuania Switzerland Cyprus Macau Syria
  • 제품 설명
    Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. || Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. || Strata Valve Magnet Reverse Polarity (Excludes StrataMR). || Catalog No. || 27739 || 27740 || 27786 || 27787 || 27788 || 27789 || 27794 || 27812 || 27814 || 27815 || 27816 || 27817 || 27818 || 27820 || 27821 || 27822 || 27823 || 27824 || 27825 || 27827 || 27828 || 27830 || 27831 || 27832 || 27848 || 27864 || 27867 || 27868 || 27888 || 27903 || 27922 || 27823 || 27924 || 23042 || 27925 || 27926 || 27927 || 27932 || 27933 || 42335 || 42355 || 42365 || 42836 || 42856 || 42866 || 44420 || 44421 || 44430 || 44465 || 46070 || 46075 || 46080 || 46085 || 46635 || 46655 || 46665 || 46836 || 46856 || 46866 || 46871 || 46876 || 46881 || 46886 || 92355 || 92365 || 92856 || 92866 || 96655 || 96665
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • 제조사 주소
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA