Device Recall Medtronic HeartWare HVAD System

  • 모델명 / 제조번호(시리얼번호)
    ALL SERIAL NUMBERS  UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement  1403: 00888707000116, 00888707000475  1407: '00888707000291, '00888707000727, '00888707000710,   00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472  1420: '00888707000420, '00888707000437, '00888707002660  (b) 1435: '00888707000109  1440: '00888707000260, '00888707001885, '00888707001496,  '00888707002745  (c) 1425: '00888707000093  1430: '00888707000307, '00888707000826, '00888707000833,  '00888707000840, '00888707000857, '00888707000871, '00888707000864,  '00888707000888, '00888707000901, '00888707000505, '00888707000895,  '00888707000918, '00888707001489, '00888707001779, '00888707001786,  '00888707001793, '00888707001809, '00888707001816, '00888707001823,  '00888707001830, '00888707001847, '00888707001854, '00888707001861,  '00888707001878, '00888707002738, '00888707002769, '00888707002776,  '00888707002783, '00888707002790, '00888707002806, '00888707004817  (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653,  '00888707000376
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, and Vietnam.
  • 제품 설명
    Heartware Medtronic HVAD System for cardiac use. Including the following parts: || (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 || (b) DC Adapter, Product numbers: 1435, 1440 || (c) AC Adapter, Product numbers: 1425, 1430 || (d) Battery Pack, Product number: 1650DE || Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Heartware, 14400 NW 60th Ave, Miami Lakes FL 33014-2807
  • 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