Events

Recall of Device Recall Medtronic Trillium AFFINITY NT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic International Trade Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48101
  • Event Risk Class
    Class 2
  • Event Number
    Z-2005-2008
  • Event Initiated Date
    2008-05-07
  • Event Date Posted
    2008-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70837
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    cardiovascular bypass oxygenator - Product Code DRY
  • Reason
    Medtronic is advising that certain trillium-coated medtronic cardiopulmonary bypass (cbp) products (e.G., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (oscs). based upon currently available information, medtronic has determined that medtronic trillium-coated products can continue to be used in cardiopulm.
  • Action
    Medtronic Cardiovascular Customers were sent the May 05, 2008 Urgent Medical Device Corrective Action letter to advise them that certain Trillium-coated cardiopulmonary bypass products were manufactured with heparin which may be contaminated with oversulfated chondroitin sulfate. The letter discussed the risk evaluation and gave recommendations to healthcare professionals for patient care. Affected devices can continue to be used in cardiopulmonary bypass procedures.

Device

Device Recall Medtronic Trillium AFFINITY NT
  • 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, 95217/9857062, 95217/9858085, 95217/9858293, 95217/9860038, 95217/9861271, 95217/9861502, 95217/9862976, 95217/9863247, 95217/9864837, 95217/9865234, 95217/9865893, 95217/9866024, 95217/9866164, 95217/9868050, 95217/9868760, 95217/9870331, 95217/9870409, 95217/9870650, 95217/9871483, 95217/9872441, 95217/9874427, 95217/9875822, 95217/9877281, 95217/9877367, 95217/9877440, 95217/9877762, 95217/9879316, 95217/9880467, 95217/9880641, 95217/9881610, 95217/9881925, 95217/9881981, 95217/9882840, 95217/9883447, 95217/9883450, 95217/9884377, 95217/9884881, 95217/9886033, 95217/9888892, 95217/9888949, 95217/9888952, 95217/9889923, 95217/9890206, 95217/9891481, 95217/9891930, 95217/9892779, 95217/9894202, 95217/9894438, 95217/9895542, 95217/9895563, 95217/9895750, 95217/9897223, 95217/9897279, 95217/9897429, 95217/9897698, 95217/9898810, 95217/9898944, 95217/9898999, 95217/9900403, 95217/9900493, 95217/9900526, 95217/9900613, 95217/9900980, 95217/9901023, 95217/9901088, 95217/9901471, 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1702R51/9871082, 1A11R16/9864529, 1A11R16/9898363, 1A11R16/9900836, 1A19R26/9871079, 1B22R5/9852609, 1B22R5/9852610, 1B22R5/9876095, 1F66R12/9852612, 1F66R12/9906222, 1G47R4/9859472, 1K86R3/9812743, 1K86R3/9845548, 1K93R5/9823298, 1K93R5/9898343, 1L71R20/9904065, 1M05R12/9882585, 1P07R6/9849635, 1P07R6/9906224, 1P07R6/9909834, 1X24R/9828429, 1X24R/9882586, 2892R18/9823305, 2D64R12/9849668, 2D64R12/9849669, 2D64R12/9898367, 2E55R9/9842027, 2E55R9/9895126, 2E55R9/9895127, 2N90R8/9898372, 2V85R4/9898358, 3B89R12/9859504, 3C98R7/9849639, 3C98R7/9849640, 3P11R4/9818271, 3P11R4/9894029, 3R39R2/9848260, 3R39R2/9876345, 3R39R2/9911074, 3R42R14/9900843, 3R42R14/9900844, 4B46R16/9849670, 4E58R16/9856481, 4F13R2/9856483, 4J01R7/9891239, 4Q39R1/9864519, 4Q39R1/9906234, 4R68R5/9836720, 4R68R6/9906246, 4W65R/9842003, 4X44R7/9866759, 5633R30/9842026, 5C89R2/9845566, 5D83R/9866760, 5R69R1/9875367, 5R69R1/9895326, 5U35R/9929024, 9059R20/9842010, 9059R20/9900837, 9243R19/9845568, 9243R19/9895319, 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, M390206E/200973465, M390322C/200957117, M390508D/200971872, M390824C/200933406, M390824C/201017510, M391817L/200948854, M391817M/200974967, M391908B/200945741, M391908B/200990138, M392814A/200977455, M392814A/201001630, M392814A/201034510, M392815A/200950055, M395216B/200962721, M395216B/200985176, M395217B/200933306, M395217B/200971868, M395319B/200973265, M396010D/200970167, M397013G/200950190, M397013G/201001823, M397912B/200935634, M397912B/201049318, M398309C/200984061, M398309C/201014558, M399510A/200975056, M399511A/200964869, M399511A/201017354, M410811K/200935071, M410811L/200977489, M430737A/200973327, M430737A/201054543, M443307B/201039509, M443822B/200976415, M443822B/201054699, M443823B/200976416, M443823B/201054695, M447005R/200978551, M460524D/200949744, M460530B/200949742, M460530B/200966981, M460531B/200999992, M460532B/200926957, M460532B/200966932, M460532B/200999981, M462007B/200991873, M462007B/201021499, M470233C/200974975, M470233C/201029764, M470237C/200975131, 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, TL3T11R11/9900024, TL3T11R11/9900024, TL3V10R11/9874853, TL3V42R6/9904031, TL3V42R6/9914075, TL3V42R6/9919254, TL3X14R3/9856420, TL3X14R4/9909961, TL3X86R5/9906215, TL3Y45R1/9881136, TL3Y45R1/9891218, TL3Y70R1/9924750, TL3Y77R/9864490, TL3Y77R/9898337, TL3Y77R/9900811, TL3Z02R4/9887333, TL3Z07R/9852606, TL3Z07R/9895270, TL3Z67R4/9845542, TL4A55R19/9874941, TL4A76R/9866737, TL4A98R1/9856421, TL4A98R1/9856422, TL4A98R1/9909804, TL4B15R2/9818238, TL4B16R5/9859493, TL4C84R/9859466, TL4D71R1/9895289, TL4E06R1/9904071, TL4E30R11/9879885, TL4F57R2/9919260, TL4F60R/9834322, TL4F71R1/9859497, TL4F71R1/9891235, TL4F88R6/9871078, TL4F97R7/9864517, TL4H65R/9885464, TL4H65R/9909805, TL4H98R1/9909892, TL4J16R/9909806, TL4J32R10/9845571, TL4J32R10/9906244, TL4J32R10/9909956, TL4J96R7/9895309, TL4J96R7/9906235, TL4J96R7/9909902, TL4K33R3/9864974, TL4K33R3/9883915, TL4K33R3/9895124, TL4K33R3/9929052, TL4K78R/9914187, TL4K84R8/9911087, TL4K88R/9856456, TL4K93R/9895307, TL4K93R/9909889, TL4K95R3/9874933, 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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
    Cardiovascular Devices
  • 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
    Medtronic International Trade Inc

Manufacturer

Medtronic International Trade Inc
  • Manufacturer Address
    Medtronic International Trade Inc, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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