Device Recall Medtronic Custom Perfusion System

  • 모델명 / 제조번호(시리얼번호)
    Lot: 12096267, 12105099, 12139669, 12166396, 12198322, 12309957, 12416020, 206119223, 206120062, 206180336, 206233199, 206384131, 206496179, 206649807, 206699258, 206758209, 206851971, 206864385, 206919887, 207003072, and 207071455.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
  • 제품 설명
    Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. || Sterilized by Ethylene Oxide, Do no Reuse. || Product Usage: Usage: || This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot: 11110924, 11178379, 11281864, 11341336, 11346822, 11357000, 11386060, 11387461, 11412023, 11448066, 11501190, 11506220, 11506223, 11528161, 11552139, 11577959, 11600953, 11623004, 11664710, 11672387, 11718344, 11719034, 11736936, 11816427, 11839402, 11843611, 11869817, 11896503, 11930457, 11995799, 11995883, 12000022, 12024743, 12024776, 12075385, 12093515, 12096289, 12166420, 12249817, 12264661, 12309956, 12374421, 12411720, 206168235, 206219230, 206325047, 206388493, 206476804, 206581948, 206597875, 206689812, 206709358, 206720707, 206851972, 206852054, 206864691, 206904419, 206991490, 207003054, 207100337, and 207121513.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
  • 제품 설명
    Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. || Sterilized by Ethylene Oxide, Do no Reuse. || Product Usage: || This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot: 11646955, 11669565, 11672312, 11713195, 11724203, 11749965, 11750036, 11787651, 11799982, 11822299, 11822308, 11878727, 11892549, 11908754, 11977672, 11982378, 11990416, 12019895, 12033691, 12075354, 12089790, 12096228, 12105079, 12111165, 12139696, 12155284, 12172596, 12178118, 12182890, 12191658, 12204951, 12204958, 12221793, 12227544, 12233759, 12236465, 12292171, 12323842, 12385431, 12399363, 12403798, 206110970, 206141990, 206142625, 206388507, 206476850, 206618547, 206649829, 206720637, 206758173, 206758215, 206851679, 206919848, 207003064, and 207030516.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
  • 제품 설명
    Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. || Sterilized by Ethylene Oxide, Do no Reuse. || Product Usage: Usage: || This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
  • Manufacturer