Events

Retiro De Equipo (Recall) de 6F Taiga Guiding Catheter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79449
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1207-2018
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162346
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Catheter, percutaneous - Product Code DQY
  • Causa
    Complaints regarding 6f taiga guide catheter tip detachment and/or tip splitting.
  • Acción
    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.

Device

6F Taiga Guiding Catheter
  • Modelo / Serial
    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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Japan
  • Descripción del producto
    6F Taiga Guiding Catheter
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Dirección del fabricante
    Medtronic Inc, 710 Medtronic Pkwy, NE Mailstop LS245, Minneapolis MN 55432-5603
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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