Recalls / —

—#162346

Product

6F Taiga Guiding Catheter

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K083422
Affected lot / code info: Lot/Serial Number's: 0008104881, 0008185945, 0008448845, 0008498609, 0008591678, 0008603130, 0008128237, 0008185937, 0008359341, 0008381347, 0008520748, 0008572204, 0008584614, 00 887489, 0008132544, 0008143685, 0008153935, 0008176874, 0008181991, 0008189749, 0008195422, 0008220305, 0008399842, 0008411526, 0008479077, 0008498645, 0008510155, 0008560305, 0008588040, 0008609897, 0008614083, 0008092512, 0008117850, 0008171020, 0008173080, 0008185946, 0008195426, 0008250618, 0008374572, 0008399835, 0008411525, 0008510141, 0008584625, 0008589932, 0008609899, 0008084699, 0008092511, 0008143683, 0008156792, 0008169119, 0008191347, 0008448842, 0008479041, 0008498608, 0008527623, 0008090683, 0008121917, 0008128241, 0008148608, 0008169116, 0008191339, 0008401589, 0008503947, 0008510133, 0008580930, 0008580935, 0008580939, 0008589915, 0008121924, 0008132534, 0008150901, 0008401588, 0008418561, 0008441398, 0008448854, 0008503956, 0008588042, 0008603140, 0008614065, 0008087481, 0008090682, 0008132516, 0008498612, 0008510146, 0008572210, 0008580937, 0008588036, 0008603136, 0008123258, 0008165872, 0008490748, 0008498648, 0008143680, 0008399813, 0008090684, 0008128251, 0008169124, 0008181983, 0008185942, 0008436912, 0008448835, 0008458396, 0008471810, 0008481006, 0008492425, 0008498642, 0008503965, 0008588039, 0008150909, 0008381364, 0008440030, 0008448837, 0008492428, 0008580933, 0008580936, 0008580940, 0008603142, 0008236362, 0008506201, 0008440025, 0008158841, 0008589929, 0008117834, 0008140160, 0008140158, 0008584612, 0008140153, 0008588035, 0008087497, 0008117854, 0008171017, 0008181987, 0008185949, 0008189738, 0008195429, 0008227448, 0008240516, 0008349924, 0008374578, 0008407407, 0008428073, 0008440040, 0008492417, 0008506206, 0008589931, 0008600840, 0008603138, 0008614075, 0008090688, 0008135876, 0008169120, 0008173078, 0008180039, 0008498627, 0008510129, 0008572207, 0008579087, 0008579090, 0008591671, 0008609888, 0008117843, 0008132532, 0008150894, 0008233403, 0008381360, 0008416713, 0008479070, 0008503958, 0008525960, 0008555947, 0008586326, 0008600838, 0008606084, 0008609893, 0008614068, 0008169125, 0008284846, 0008361412, 0008436904, 0008586324, 0008609886, 0008087503, 0008098497, 0008108533, 0008123259, 0008132523, 0008132525, 0008144679, 0008144680, 0008171009, 0008177970, 0008193508, 0008218499, 0008225407, 0008231701, 0008242807, 0008329311, 0008342126, 0008349912, 0008365450, 0008374574, 0008388047, 0008407404, 0008418572, 0008428085, 0008454371, 0008456337, 0008479051, 0008479057, 0008503968, 0008518382, 0008529633, 0008546593, 0008564278, 0008588045, 0008591673, 0008603126, 0008614073, 0008623891, 0008117853, 0008165878, 0008181992, 0008185944, 0008195428, 0008312796, 0008351878, 0008418565, 0008479074, 0008510154, 0008564276, 0008584618, 0008589912, 0008603129, 0008606081, 0008611517, 0008102481, 0008128253, 0008135881, 0008150887, 0008181978, 0008181986, 0008185943, 0008189756, 0008227450, 0008242808, 0008340383, 0008349919, 0008420672, 0008458398, 0008492395, 0008506212, 0008525964, 0008551253, 0008572205, 0008589917, 0008603128, 0008609901, 0008117851, 0008132537, 0008175028, 0008185950, 0008216634, 0008403383, 0008411523, 0008490750, 0008498619, 0008510157, 0008582358, 0008582365, 0008591677, 0008121922, 0008143687, 0008171022, 0008189732, 0008189735, 0008436903, 0008448844, 0008481008, 0008498655, 0008510162, 0008588038, 0008090677, 0008102474, 0008135875, 0008143672, 0008164709, 0008169123, 0008498630, 0008520751, 0008572209, 0008586333, 0008589923, 0008606085, 0008611515, 0008572203, 0008591669, 0008609882, 0008102479, 0008185939, 0008132520, 0008169118, 0008483192, 0008498601, 0008503941, 0008087476, 0008102476, 0008483190, 0008242802, 0008471804, 0008506203, 0008603124, 0008381351, 0008164710, 0008418558, 0008510130, 0008164708, 0008346263, 0008503943, 0008546591, 0008564272, 0008175029, 0008205770, 0008407402, 0008411528, 0008498610, 0008591675, 0008227447, 0008312798, 0008448846, 0008492399, 0008202461, 0008555943, 0008087496, 0008117847, 0008456325, 0008468606, 0008479024, 0008506202, 0008535437, 0008544524, 0008572206, 0008580931, 0008586328, 0008598736, 0008609890, 0008087487, 0008106137, 0008376553, 0008586331, 0008368954, 0008488926, 0008284838, 0008084670, 0008128239, 0008169121, 0008416708, 0008428066, 0008440042, 0008479036, 0008492411, 0008498639, 0008527622, 0008586325, 0008614071, 0008092505,0 008117833, 0008128245, 0008242801, 0008370458, 0008510125, 0008102483, 0008132546, 0008148619, 0008164716, 0008176875, 0008189753, 0008191353, 0008220302, 0008329308, 0008349916, 0008409469, 0008428081, 0008441401, 0008479063, 0008503951, 0008572215, 0008589930, 0008600843, 0008606089, 0008614074, 0008535445, 0008128252, 0008140156, 0008148612, 0008153932, 0008171001, 0008191340, 0008221979, 0008436905, 0008454370, 0008468609, 0008488931, 0008492384, 0008500611, 0008506210, 0008515021, 0008525962, 0008537068, 0008579084, 0008579089, 0008591670, 0008606087, 0008092510, 0008104886, 0008128254, 0008135880, 0008150904, 0008164714, 0008175025, 0008189754, 0008191355, 0008218508, 0008242806, 0008374575, 0008401594, 0008420670, 0008436908, 0008479066, 0008500614, 0008531592, 0008572214, 0008591674, 0008603144, 0008614081, 0008132517, 0008140167, 0008143689, 0008148615, 0008150892, 0008181984, 0008189733, 0008189736, 0008242803, 0008436902, 0008448834, 0008458395, 0008468607, 0008479032, 0008490738, 0008500613, 0008503955, 0008520750, 0008560309, 0008591676, 0008405710, 0008411524, 0008440026, 0008448850, 0008481005, 0008510144, 0008546588, 0008580934, 0008586327, 0008614069, 0008087483, 0008090680, 0008132514, 0008140161, 0008148610, 0008165873, 0008242800, 0008448838, 0008468608, 0008498604, 0008537076, 0008579088, 0008589920, 0008611518, 0008090681, 0008102478, 0008128243, 0008140163, 0008164711, 0008175027, 0008117837, 0008095214, 0008121930, 0008165880, 0008175026, 0008189740, 0008191345, 0008195427, 0008374580, 0008399831, 0008424958, 0008441396, 0008448839, 0008492392, 0008498654, 0008503963, 0008535442, 0008572208, 0008586330, 0008586332, 0008589933, 0008598737, 0008603143, 0008143682, 0008171013, 0008208233, 0008448855, 0008492430, 0008506205, 0008537074, 0008562621, 0008589918, 0008603134, 0008611516, 0008084683, 0008095212, 0008121927, 0008132529, 0008156793, 0008169127, 0008189750, 0008195425, 0008216629, 0008242805, 0008351874, 0008368955, 0008374583, 0008418570, 0008441407, 0008479038, 0008506213, 0008535448, 0008551249, 0008572212, 0008589934, 0008600841, 0008611521, 0008090685, 0008128242, 0008143691, 0008165882, 0008177971, 0008399825, 0008440033, 0008471807, 0008492382, 0008506208, 0008537078, 0008582366, 0008588037, 0008603132, 0008609895, 0008090676, 0008600837, 0008621626, 0008090675, 0008479023, 0008503960, 0008548757, 0008560294, 0008582359, 0008582368, 0008603133, 0008128234, 0008490737, 0008498615, 0008584623, 0008202458, 0008441391, 0008498618, 0008140165, 0008560285, 0008140150, 0008488921, 0008104887, 0008479027, 0008490740, 0008143674, 0008397725, 0008092504, 0008153924, 0008096759, 0008492379, 0008582360, 0008102477, 0008359340, 0008582361, 0008611513, 0008150881, 0008498652, 0008525959, 0008564274, 0008092508, 0008102480, 0008132528, 0008148613, 0008164715, 0008171025, 0008181979, 0008181989, 0008185951, 0008191341, 0008195432, 0008205771, 0008212336, 0008218503, 0008231699, 0008236364, 0008347562, 0008352965, 0008374576, 0008390327, 0008401590, 0008405712, 0008409466, 0008428077, 0008479035, 0008485259, 0008503938, 0008518377, 0008560298, 0008584622, 0008589911, 0008603127, 0008606088, 0008611514, 0008614077, 0008535441, 0008128248, 0008132540, 0008150890, 0008169126, 0008181977, 0008181981, 0008185948, 0008191342, 0008208232, 0008221977, 0008240515, 0008312792, 0008357550, 0008374582, 0008399821, 0008411532, 0008428070, 0008456333, 0008479047, 0008490744, 0008503954. 0008518378. 0008584621, 0008589919. 0008609891. 0008616444. 0008537070, 0008095215, 0008117845, 0008171011, 0008189752, 0008420666, 0008448840, 0008454369, 0008483198, 0008503966, 0008518385, 0008584620, 0008589913, 0008603141, 0008128250, 0008135878, 0008185941, 0008191344, 0008498621, 0008548759, 0008579086, 0008579091, 0008589910, 0008087485, 0008104880, 0008510126, 0008436901, 0008087504, 0008095211, 0008117855, 0008143694, 0008164713, 0008171004, 0008191346, 0008220304, 0008374577, 0008381355, 0008399817, 0008407403, 0008420668, 0008436910, 0008479043, 0008492420, 0008503959, 0008515023, 0008562623, 0008582367, 0008584626, 0008589925, 0008600842, 0008614066, 0008535451, 0008095213, 0008165884, 0008181990, 0008189748, 0008202468, 0008216623, 0008333048, 0008397728, 0008479026, 0008490739, 0008510139, 0008546592, 0008560290, 0008584624, 0008589914, 0008606083, 0008403381, 0008503961, 0008582362, 0008582369, 0008169122, 0008555937, 0008580932, 0008203696, 0008121920, 0008117836, 0008132519, 0008158808, 0008169117, 0008312795, 0008498623, 0008518379, 0008582363, 0008586329, 0008603139, 0008092506, 0008128244, 0008150884, 0008170999, 0008090690, 0008104882, 0008121937, 0008148621, 0008165876, 0008175023, 0008191351, 0008195431, 0008225404, 0008240517, 0008390326, 0008401592, 0008416711, 0008456328, 0008483194, 0008492402, 0008506207, 0008562625, 0008588044, 0008535454, 0008121941, 0008143681, 0008148614, 0008153929, 0008158840, 0008173079, 0008189737, 0008195424, 0008416706, 0008440028, 0008448843, 0008458394, 0008490746, 0008503957, 0008510135, 0008589927, 0008611519, 000810 884, 0008128236, 0008150907, 0008164712, 0008181985, 0008418567, 0008436906, 0008456330, 0008492406, 0008510159, 0008560301, 0008586334, 0008589928, 0008606082, 0008614070, 0008121933, 0008132518, 0008150897, 0008175030, 0008208228, 0008335373, 0008344295, 0008510137, 0008582364, 0008589916, 0008606080, 0008580941, 0008591672, 0008173077, 0008169115, 0008098495, 0008164707, 0008498606, and 0008589924.

Why it was recalled

Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

A recall notification was sent to all costumers in September 2017. Customers actions to be done: Identify and quarantine all unused affected products as listed in your inventory. Share notification with others who need to be aware where affected product may have potentially been transferred.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy NE, Mailstop LS245, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: Japan

Timeline

Recall initiated: 2017-09-26
Posted by FDA: 2018-03-29
Terminated: 2021-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162346. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.