Medtronic Cardiovascular Surgery-the Heart Valve Division

  • 제조사 주소
    Medtronic Cardiovascular Surgery-the Heart Valve Division, 1851 E Deere Ave, Santa Ana CA 92705-5720
  • 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
  • 4 Events

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 4 건

  • 모델명 / 제조번호(시리얼번호)
    Model 7305.  Lot/Serial Numbers:  The catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD.  Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide)
  • 제품 설명
    Product Name: Model 7305- Mosaic Aortic Obturator || The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
  • 모델명 / 제조번호(시리얼번호)
    all lots
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. || Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: B146341, B146350
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of MD and TX.
  • 제품 설명
    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. || Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
  • 모델명 / 제조번호(시리얼번호)
    0007254814 0007266413 0007332504 0007332506 0007332508 0007332510 0007343321 0007343324 0007343327 0007350825 0007350837 0007354113 0007354245 0007366949 0007369883 0007393098 0007393101 0007408862 0007408865 0007408867 0007408869 0007428258 0007428260 0007428263 0007435169 0007439358 0007439360 0007439362 0007456292 0007456298 0007462901 0007462903 0007462905 0007476215 0007476217 0007476219 0007482219 0007482222 0007482226 0007486826 0007492356 0007495691 0007495694 0007495696 0007508883 0007508885 0007508891 0007515698 0007515700 0007515703 0007522595 0007522598 0007522600 0007522603 0007530963 0007530973 0007537892 0007537894 0007569474 0007569477 0007569482 0007573778 0007573785 0007573788 0007573791 0007579940 0007579944 0007579948 0007579951 0007592664 0007592666 0007592669 0007592672 0007598984
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
  • 제품 설명
    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. || Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.