Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall 6F Taiga Guiding Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall 6F Taiga Guiding Catheter see related information
Date Initiated by Firm September 26, 2017
Date Posted March 29, 2018
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1207-2018
Recall Event ID 79449
510(K)Number K083422  
Product Classification Catheter, percutaneous - Product Code DQY
Product 6F Taiga Guiding Catheter
Code Information 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. 
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
NE Mailstop LS245
Minneapolis MN 55432-5603
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall		 Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 15,923
Distribution Japan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = MEDTRONIC VASCULAR
-
-