Micro Therapeutics Inc, dba ev3 Neurovascular

  • 제조사 주소
    Micro Therapeutics Inc, dba ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 제조사 모회사 (2017)
  • 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
  • 3 Events

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 3 건

  • 모델명 / 제조번호(시리얼번호)
    Lot # 7964590
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.
  • 제품 설명
    Axium Detachable Coil System QC-7-30-Helix || The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.
  • 모델명 / 제조번호(시리얼번호)
    Lot # 7964576
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.
  • 제품 설명
    Axium Detachable Coil System QC-2-1-Helix || The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 5871057
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of CA, CT, NE, NV, and WI. and the countries of Argentina, Brazil, Colombia, and Egypt.
  • 제품 설명
    Axium Detachable Coil System Model Number: QC-2-2-3D. || The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Micro Therapeutics Inc, Dba Ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 제조사 모회사 (2017)
  • 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