Device Recall Medtronic Trillium Affinity

  • Model / Serial
    Lot Numbers 8870107 and 8851934 (both Model 541T )
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.
  • Product Description
    Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
  • Product Description
    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T || The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
  • Manufacturer
  • Model / Serial
    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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9243R19/9909937, CB0A12R15/9818152, CB2T58R4/9869742, CB3L15R5/9853896, CB3L15R5/9904049, CB4D99R4/9915505, CB4E05R6/9828459, CB4E05R6/9874930, CB4J24R2/9906207, CB4J67R1/9895280, CB4K47R1/9909756, CB4K64R5/9856461, CB5B53R/9882599, CB5B53R/9915507, CB5C01R2/9864545, CB5C82R9/9864546, CB5C82R9/9864653, CB5P29R4/9871450, CB5P29R4/9914212, CB5Q88R/9861123, CB5S97R2/9921078, DP38T/9874904, DP38T/9904640, HY0W55R17/9808971, HY0W55R17/9910794, HY0Y86R17/9895142, HY0Y86R17/9895324, HY1709R34/9914044, HY1C73R16/9856469, HY2F13R22/9836729, HY2F13R23/9916965, HY2J04R2/9856414, HY2K12R5/9900680, HY2K16R5/9861559, HY2K16R5/9897791, HY2K51R14/9853921, HY2K51R14/9871066, HY2K51R14/9897797, HY2K60R3/9828457, HY2Q31R1/9856468, HY2Q32R2/9909790, HY2T49R3/9898330, HY2U43R5/9895125, HY2U98R5/9909926, HY2W85R9/9849675, HY2W85R9/9849676, HY2W85R9/9849677, HY3B29R13/9895322, HY3C53R1/9871041, HY3E77R13/9849120, HY3H52R13/9895169, HY3L42R12/9866761, HY3L42R12/9886081, HY3L78R1/9923377, HY3M41R4/9849658, HY3M43R1/9828413, HY3M45R1/9864484, HY3Q11R14/9895138, HY3Q11R14/9895139, HY3T77R2/9896464, HY3T77R2/9898435, HY3U59R4/9865471, HY3U59R4/9923417, HY4A96R3/9828227, HY4B44R/9874912, HY4B50R/9864521, HY4E05R8/9909957, HY4E66R5/9855421, HY4V82R2/9882601, HY4X31R7/9914047, HY4Y15R11/9897011, HY4Y15R11/9907958, HY4Z59R7/9902612, HY4Z62R5/9882303, HY5C74R15/9871083, HY5D07R/9864530, HY5D70R1/9853933, HY5D70R1/9909930, HY5L38R1/9904073, HY5L38R1/9918472, HY5N41R2/9869677, HY5N42R3/9900846, HY5P52R/9877621, HY5P52R/9902248, HY5Q00R/9857173, HY5S13R/9911027, HY5S33R2/9922456, JP1Z53R11/9860355, M310113Q/200986523, M310113Q/201017351, M310319A/201004514, M310523D/200960594, M310523D/200983800, M310523D/201014186, M310525C/200776830, M310525C/200914593, M310525C/200999719, M310531G/200951787, M310538A/200767906, M310538A/200998230, M310543F/200933365, M310543F/200968691, M310543F/200996499, M310824V/200986605, M310824V/201017488, M310852C/200946515, M310854A/200946514, M311028K/200937915, M311028K/200971865, M311028K/201025580, M311224A/200970165, M311224A/200996653, M311818C/200979740, M320234E/200951680, M320410V/201011466, M320608K/200991864, M320608K/201021498, M321014K/200995749, M321505L/200973472, M322318C/200945750, M322318C/200973463, M330112G/200983044, M330344D/200973338, M330607H/200978376, M332108C/201004516, M332108C/201029676, M332607G/200996493, M333405W/200986410, M333809B/200972405, M334007C/200926570, M334007C/200974974, M334007C/201033042, M334008D/200962670, M334008D/200978372, M334209A/200974961, M334209A/200984671, M334209A/201016613, M335615B/200995752, M336202V/200978364, M336202V/201011474, M337412A/200962585, M337412A/201017359, M337414A/200962660, M337414A/201020119, M337414A/201029347, M337415A/200950040, M337415A/200977462, M337417A/200984626, M337418B/200984630, M337418B/201016607, M338001P/200981099, M338001P/201024768, M340305C/200936579, M340615E/200972408, M343105G/200979741, M380324D/200978556, M380324D/201012978, M390206E/200948497, 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M470945S/200933318, M470945S/200971849, M470945T/201001926, M490750B/200938518, M495512K/200987075, M495512K/201004645, M580211B/200957101, M580211B/201036281, M580416B/200945726, M580416B/201024718, M580418E/200983048, M720407F/200968561, M720409F/200938479, M720409F/200974976, M720714C/200938466, M720714C/200973329, M720714C/201001639, M720718D/200968698, M720718D/200973667, M720720B/200964933, M930401B/200922137, M930402B/200922135, M960116A/200979559, M960119A/200979558, M973502E/200984001, M973502E/201013844, M973901C/200813720, M999308D/200948517, M999308D/200974969, P391401B/200953133, P391401B/201054693, TL0A42R21/9882593, TL0W56R7/9868069, TL1E95R12/9909898, TL1J50R3/9658714, TL2C82R4/9923403, TL2H89R7/9898365, TL2J77R/9841963, TL2K45R6/9845562, TL2K45R6/9900831, TL2L66R5/9895285, TL2L66R5/9909791, TL2L67R/9898332, TL2M25R6/9854038, TL2P63R1/9856415, TL2P93R5/9904074, TL2P94R9/9906240, TL2R00R3/9856416, TL2R00R3/9909792, TL2R66R/9874913, TL2S03R4/9906233, TL2S03R4/9909890, TL2S21R1/9836684, TL2S24R3/9874935, TL2S80R24/9853927, TL2S80R30/9868071, TL2S80R30/9885490, TL2S80R30/9897798, TL2T46R7/9915448, TL2U42R13/9849687, TL2U42R13/9898371, TL2U59R/9895286, TL2W21R/9849620, TL2W22R5/9923378, TL2W90R11/9879897, TL2Z00R4/9895111, TL2Z34R/9909795, TL2Z35R/9915484, TL3A08R16/9891237, TL3B47R8/9841965, TL3C66R4/9864486, TL3C66R4/9864487, TL3C69R16/9828450, TL3E97R5/9845541, TL3E98R7/9921079, TL3E99R2/9885607, TL3F17R2/9898451, TL3F33R1/9919253, TL3G03R2/9871067, TL3G89R1/9593332, TL3G89R1/9898334, TL3H76R12/9846723, TL3H85R1/9891217, TL3H86R6/9911088, TL3K26R8/9809022, TL3L73R5/9895287, TL3L73R5/9923379, TL3M00R7/9879882, TL3M35R14/9863156, TL3M35R14/9868110, TL3M92R1/9911060, TL3N21R3/9864488, TL3N58R1/9926687, TL3P08R4/9849753, TL3P08R4/9923415, TL3P79R8/9875092, TL3P79R8/9910788, TL3R32R4/9808976, TL3R32R4/9871042, TL3R79R4/9887326, TL3R82R6/9856417, TL3R82R6/9856418, TL3R95R3/9915500, TL3S25R/9887067, TL3S39R3/9925910, TL3S63R/9898336, TL3T02R2/9812851, 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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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including USA.
  • Product Description
    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
  • Manufacturer