Medtronic International Trade Inc

  • 제조사 주소
    Medtronic International Trade Inc, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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
  • 1 Event

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

  • 모델명 / 제조번호(시리얼번호)
    MODEL # / LOT #: 95215/9834158, 95215/9836054, 95215/9840678, 95215/9841550, 95215/9841559, 95215/9845071, 95215/9847467, 95215/9850444, 95215/9855692, 95215/9856192, 95215/9862423, 95215/9864967, 95215/9866563, 95215/9868270, 95215/9871572, 95215/9874613, 95215/9875139, 95215/9882831, 95215/9884748, 95215/9889245, 95215/9891467, 95215/9892254, 95215/9918684, 95216/9842281, 95216/9846078, 95216/9849122, 95216/9851739, 95216/9858463, 95216/9864836, 95216/9870318, 95216/9870329, 95216/9881577, 95216/9885872, 95216/9890513, 95216/9892011, 95216/9895530, 95216/9896568, 95216/9904481, 95216/9905578, 95216/9905755, 95216/9907437, 95216/9911601, 95216/9912191, 95217/9837473, 95217/9837609, 95217/9837669, 95217/9838938, 95217/9839026, 95217/9842333, 95217/9842382, 95217/9842493, 95217/9844162, 95217/9845850, 95217/9846383, 95217/9847644, 95217/9848942, 95217/9849195, 95217/9849848, 95217/9850346, 95217/9851508, 95217/9852863, 95217/9853060, 95217/9854098, 95217/9856703, 95217/9856833, 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TS8390R5/0000702343, TS8390R5/0000725136, TS8397R5/0000725229, TS9412R4/0000680661, TS9412R4/0000686889, TS9412R4/0000700908, TS9412R4/0000700973, TS9412R4/0000704567, TS9412R4/0000715042, TS9412R4/0000721788, TS9416R1/0000666539, TS9416R2/0000676111, TS9416R2/0000689000, TS9416R2/0000696021, TS9416R2/0000709244, TS9416R2/0000711304, TS9416R2/0000721652, TS9416R2/0000723021, TS9420R4/0000724092, TS9422R35/0000673932, TS9422R35/0000677981, TS9422R35/0000683408, TS9422R35/0000688056, TS9422R35/0000690443, TS9422R35/0000698349, TS9422R35/0000699661, TS9422R35/0000702214, TS9422R35/0000709158, TS9422R35/0000713968, TS9422R35/0000726432, TS9422R35/0000727315, TS9423R2/0000666496, TS9423R2/0000686906, TS9423R3/0000674357, TS9423R3/0000682606, TS9423R3/0000693024, TS9423R3/0000696183, TS9423R3/0000703124, TS9423R3/0000724042, TS9425R38/0000675106, TS9425R38/0000687713, TS9425R38/0000687714, TS9425R38/0000696016, TS9425R38/0000705319, TS9425R38/0000707057, TS9425R38/0000716291, TS9425R38/0000726244, TS9749R27/0000680595, TS9749R27/0000683301, TS9749R27/0000690189, TS9749R27/0000695318, TS9749R27/0000699634, TS9749R27/0000712301, TS9749R27/0000713764, TS9749R27/0000716440, TS9749R27/0000720350, TS9749R27/0000724869, TS9749R27/0000726185, TS9781R11/0000665814, TS9781R12/0000676648, TS9781R12/0000681386, TS9781R12/0000691170, TS9781R12/0000700771, TS9781R12/0000711279, TS9781R12/0000725107, TS9800R30/0000674358, TS9800R30/0000674384, TS9800R30/0000675218, TS9800R30/0000681373, TS9800R30/0000685110, TS9800R30/0000690494, TS9800R30/0000701004, TS9800R30/0000711333, TS9800R30/0000721759, TS9806R11/0000665848, TS9806R11/0000667330, TS9806R11/0000673003, TS9807R23/0000683377, TS9807R23/0000685753, TS9807R23/0000692010, TS9807R23/0000700929, TS9807R23/0000712471, TS9807R23/0000725186, TS9818R23/0000667387, TS9818R24/0000680577, TS9818R24/0000684938, TS9818R24/0000692020, TS9818R24/0000712468, TS9818R24/0000725015, TS9824R16/0000712413, TS9824R16/0000723728, TS9824R16/0000725097, TS9917R27/0000662927, TS9950R21/0000675998, TS9950R21/0000685758, TS9950R21/0000698361, TS9950R21/0000717504, TS9959R12/0000662196, TS9959R12/0000673917, TS9959R12/0000683368, TS9959R12/0000689970, TS9959R13/0000693279, TS9959R13/0000697811, TS9959R13/0000707165, TS9959R13/0000710353, TS9959R13/0000723942, XP41BT/9904032, XP41T/9866739, XP41T/9874914.
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  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including USA.
  • 제품 설명
    Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12, 1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7, 3P11R4, 3R39R2, 3R42R14, 4B46R16, 4E58R16, 4F13R2, 4J01R7, 4Q39R1, 4R68R5, 4R68R6, 4W65R, 4X44R7, 5633R30, 5C89R2, 5D83R, 5R69R1, 5U35R, 9059R20, 9243R19, CB0A12R15, CB2T58R4, CB3L15R5, CB4D99R4, CB4E05R6, CB4J24R2, CB4J67R1, CB4K47R1, CB4K64R5, CB5B53R, CB5C01R2, CB5C82R9, CB5P29R4, CB5Q88R, CB5S97R2, DP38T, HY0W55R17, HY0Y86R17, HY1709R34, HY1C73R16, HY2F13R22, HY2F13R23, HY2J04R2, HY2K12R5, HY2K16R5, HY2K51R14, HY2K60R3, HY2Q31R1, HY2Q32R2, HY2T49R3, HY2U43R5, HY2U98R5, HY2W85R9, HY3B29R13, HY3C53R1, HY3E77R13, HY3H52R13, HY3L42R12, HY3L78R1, HY3M41R4, HY3M43R1, HY3M45R1, HY3Q11R14, HY3T77R2, HY3U59R4, HY4A96R3, HY4B44R, HY4B50R, HY4E05R8, HY4E66R5, HY4V82R2, HY4X31R7, HY4Y15R11, HY4Z59R7, HY4Z62R5, HY5C74R15, HY5D07R, HY5D70R1, HY5L38R1, HY5N41R2, HY5N42R3, HY5P52R, HY5Q00R, HY5S13R, HY5S33R2, JP1Z53R11, M310113Q, M310319A, M310523D, M310525C, M310531G, M310538A, M310543F, M310824V, M310852C, M310854A, M311028K, M311224A, M311818C, M320234E, M320410V, M320608K, M321014K, M321505L, M322318C, M330112G, M330344D, M330607H, M332108C, M332607G, M333405W, M333809B, M334007C, M334007C, M334008D, M334209A, M335615B, M336202V, M337412A, M337414A, M337415A, M337417A, M337418B, M338001P, M340305C, M340615E, M343105G, M380324D, M390206E, M390322C, M390508D, M390824C, M391817L, M391817M, M391908B, M392814A, M392815A, M395216B, M395217B, M395319B, M396010D, M397013G, M397912B, M398309C, M399510A, M399511A, M410811K, M430737A, M443307B, M443822B, M443823B, M447005R, M460524D, M460530B, M460531B, M460532B, M462007B, M470233C, M470237C, M470945S, M470945T, M490750B, M495512K, M580211B, M580416B, M580418E, M720407F, M720409F, M720714C, M720718D, M720720B, M930401B, M930402B, M960116A, M960119A, M973502E, M973901C, M999308D, P391401B, TL0A42R21, TL0W56R7, TL1E95R12, TL1J50R3, TL2C82R4, TL2H89R7, TL2J77R, TL2K45R6, TL2L66R5 TL2L67R, TL2M25R6, TL2P63R1, TL2P93R5, TL2P94R9, TL2R00R3, TL2R66R, TL2S03R4, TL2S21R1, TL2S24R3, TL2S80R24, TL2S80R30, TL2S80R30, TL2T46R7, TL2U42R13, TL2U59R, TL2W21R, TL2W22R5, TL2W90R11, TL2Z00R4, TL2Z34R, TL2Z35R, TL3A08R16, TL3B47R8, TL3C66R4, TL3C69R16, TL3E97R5, TL3E98R7, TL3E99R2, TL3F17R2, TL3F33R1, TL3G03R2, TL3G89R1, TL3H76R12, TL3H85R1, TL3H86R6, || TL3K26R8, TL3L73R5, TL3M00R7, TL3M35R14, TL3M92R1, TL3N21R3, || TL3N58R1, TL3P08R4, TL3P79R8, TL3R32R4, TL3R79R4, TL3R82R6, || TL3R95R3, TL3S25R, TL3S39R3, TL3S63R, TL3T02R2, TL3T11R11, || TL3V10R11, TL3V42R6, TL3X14R3, TL3X14R4, TL3X86R5, TL3Y45R1, TL3Y70R1, TL3Y77R, TL3Z02R4, TL3Z07R, TL3Z67R4, TL4A55R19, TL4A76R, TL4A98R1, TL4B15R2, TL4B16R5, TL4C84R, TL4D71R1, TL4E06R1, TL4E30R11, TL4F57R2, TL4F60R, TL4F71R1, TL4F88R6, TL4F97R7, TL4H65R, TL4H98R1, TL4J16R, TL4J32R10, TL4J96R7, TL4K33R3, TL4K78R, TL4K84R8, TL4K88R, TL4K93R, TL4K95R3, TL4L34R4, TL4M16R2, TL4M22R10, TL4M94R5, TL4N20R10, TL4N27R3, TL4N84R, TL4P48R2, TL4P64R4, TL4Q43R3, TL4Q43R4, TL4R10R2, TL4R21R, TL4S97R8, TL4T06R3, TL4U93R7, TL4V76R1, TL4V77R, TL4W07R4, TL4W22R, TL4W94R1, TL4X63R1, TL4X99R8, TL4Y20R2, TL4Z28R2, TL5054R11, TL5263R2, TL5398R19, TL5398R20, TL5A39R3, TL5B82R1, TL5B83R1, TL5C29R2, TL5C35R6, TL5C63R2, TL5C64R3, TL5C97R6, TL5D45R4, TL5D65R, TL5D66R3, TL5E04R, TL5E11R1, TL5F48R, TL5F62R5, TL5F64R4, TL5F96R, TL5G03R2, TL5G04R2, TL5G26R1, TL5G27R, TL5G27R1, TL5G41R2, TL5H55R1, TL5J24R6, TL5J74R2, TL5L27R1, TL5N42R2, TL5N43R3, TL5N53R1, TL5N59R, TL5N60R, TL5N62R4, TL5N79R, TL5N94R, TL5P14R, TL5P59R2, TL5P73R2, TL5P76R2, TL5Q40R1, TL5Q76R3, TL5Q85R2, TL5Q89R1, TL5R08R, TL5R15R2, TL5R18R1, TL5R52R, TL5R57R1, TL5R91R5, TL5S53R, TL5T73R, TL5U33R, TS1259R14, TS1259R15, TS1366R3, TS1366R4, TS1366R5, TS1404R1, TS1414R3, TS1420R