Events

Retiro De Equipo (Recall) de Boston Scientific brand Matrix2 360 Standard SR Coils.

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 Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538.

¿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
    57179
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0860-2011
  • Fecha de inicio del evento
    2010-10-19
  • Fecha de publicación del evento
    2011-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96012
  • 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
    vascular embolization device - Product Code HGC
  • Causa
    The product appears to have premature degradation of the pgla coating on the matrix coil.
  • Acción
    US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.

Device

Boston Scientific brand Matrix2 360 Standard SR Coils.
  • Modelo / Serial
    Material Product Description Catalog # Batch numbers Expiry Date    11322013,11341317,11395760,11407118,   11484317,11500845,11538872,11580676,   11586996,11591704,11676172,11786207,   11800707,11843132,11889308,11889310,   11924294, 11946182, 11975161, 11975197,   Matrix2¿ 360 Standard SR Coils 12000345,12119829,12127493,12156626, Nov2010 through  M003492103SRO 492103-SR 12176110, 12194735, 12214709, 12214800,   10mm x 30cm 12214853, 12229661, 12291690, 12299408, Jun2013   12315367,12330591,12409146,12418207,   12439180,12439189,12514594,12669964,   12670044,12703195,12791152,12792881,   12863906,12909368,12913888,12921982,   13165100,13182071,13602875   11296519,11329483,11422711,11477789,   11606464,11711221,11712103,11786210,   11908091,11924295,11940396,11975180,   11996498,12009649,12112236,12119825,   Matrix2¿ 360 Standard SR Coils 12141857,12156617,12214707,12214715, Oct2010 through  M003492123SRO 492123-SR 12214861,12291695,12295742,12314469,   12mm x 30cm 12392928,12401322,12458011,12462033, Jun2013   12519869, 12523479, 12669970, 12810344,   12861691,12912140,12920952,12921980,   12921996,12982276,13164798,13165084,   13603462   Matrix2¿ 360 Standard SR Coils 11286172,11327021,11552550,11756832, Oct2010 through  M003492308SRO 492308-SR 11792451,12082838,12194728,12494078,   3mm x8cm 12947522 Aug2012   11310925,11340517,11513571,11598083,   11748422,11820289,11850852,11924296,   11940398,11975077,12007427,12026497,   Matrix2¿ 360 Standard SR Coils 12026741,12074031,12074306,12110477, Oct2010 through  M003492408SRO 492408-SR 12130818,12142084,12156609,12176095,   4mm x8cm 12176129,12214851,12304396,12418211, Dec2012   12434605, 12439350, 12579013, 12702894,   12721623,12792899,12810370,12917824,   12947545, 13164799   11289583,11341604,11500842,11622022,  M003492510SRO Matrix2¿ 360 Standard SR Coils 492510-SR 11730241, 11786201, 11820321, 12194490, Oct2010 through   5mm x 10cm 12214705, 12434606, 12450913, 12465570, Aug2012   12922017   11299199,11318111,11389194,11500843,   11550742,11606466,11697460,11711220,   11748398,11838629,11889318,11916974,   11958443,11958463,11984850,12043111,   12061948,12082851,12086034,12142091,  M003492515SRO Matrix2¿ 360 Standard SR Coils 492515-SR 12150131,12176136,12188226,12194738, Oct2010 through   5mmx15cm 12214194,12225443,12229718,12330640, Aug2013   12361044,12378759,12383763,12431052,   12439197, 12636726, 12656660, 12792894,   12805887,12861538,12861680,12899138,   12921993,12922024,12929260,12982324,   13164797,13182067,13197169,13740709   Matrix2¿ 360 Standard SR Coils 11300189,11697441,11748423,12102562, Oct2010 through  M003492610SRO 492610-SR 12194744,12650932,13109926,13201013,   6mm x 10cm 13220484 Dec2012   11281622,11311916,11314681,11491189,   11521070, 11591707, 11676160, 11730225,   11766704,11838625,11934378,11958468,   11975166,11975191,11992203,11992212,   12009577,12009653,12082842,12130810,   Matrix2¿ 360 Standard SR Coils 12142036,12161320,12168019,12176126, Oct2010 through  M003492615SRO 492615-SR 12214841,12229589,12300888,12330615,   6mmx15cm 12379816, 12388035,12409150,12427992, Dec2012   12439353, 12519870, 12549504, 12549518,   12636727, 12670053, 12721624, 12748411,   12791149, 12792892, 12861690, 12889253,   12912271,12922000,12947541,12982277,   13016751,13165091   Matrix2¿ 360 Standard SR Coils 11311649,11552534,11697440,11697450, Oct2010 through  M003492715SRO 7mm x 15cm 492715-SR 11766703,12176124,12229551,12372622, Dec2012   12494180,12698228,12922016,13201014 11325958,11330877,11448223,11516241,   11591599, 11640896, 11676142, 11676149,   11766671, 11786209, 11795499, 11820176,   11868816,11925596,11975072,11975182,   11992202,11992218,12009562,12009570,  M003492720SRO Matrix2¿ 360 Standard SR Coils 492720-SR 12051397,12082854,12142030,12188227, Nov2010 through   7mm x20cm 12194711,12194747,12214845,12225440, Jul2013   12291691,12299412,12314471,12324046,   12355111,12401321,12409152,12418208,   12427990,12636754,12810346,12841940,   12861722, 12917822, 12922005, 12947520,   12947528, 13165089, 13705204   11303726, 11344541, 11491183, 11597978,   11697453,11730059,11766677,11800708,  M003492820SRO Matrix2¿ 360 Standard SR Coils 492820-SR 11836538,11838623,11958239,12043226, Oct2010 through   8mm x20cm 12130809,12194736,12260123,12388030, Jun2013   12669969, 12791148, 12792880, 12922002,   13201015, 13202909, 13606213   11310595,11410936,11470446,11552546,   11606467,11658788,11712109,11766665,   11800187,11838294,11869782,11925588,   11975179,11992216,12009571,12043110,   Matrix2¿ 360 Standard SR Coils 12061953, 12069212, 12074311, 12119903, Oct2010 through  M003492830SRO 492830-SR 12150137,12188230,12194489,12194704,   8mm x30cm 12229669, 12291686, 12296707, 12314472, Dec2012   12330585,12356257,12361056,12636753,   12669979, 12703142, 12753169, 12783354,   12792913, 12895634, 12899136, 12912676,   12922009,13165096  .,tl003492920SRO Matrix2¿ 360 Standard SR Coils 492920-SR 11318113,11441724,11542877,11711222, Nov2010 through   9mm x20cm 11838626,12150132,12579018,13614169 Jun2013   11290201,11318378,11403946,11488185,   11520165,11598081,11658797,11748390,   11889313,11940587,11952858,12009643,   12026498,12061945,12069211,12074037,   Matrix2¿ 360 Standard SR Coils 12130804,12176121,12194485,12194498, Oct2010 through  M003492930SRO 492930-SR 12194734,12229597,12295451,12296708,   9mm x 30cm 12325703,12355110,12549418,12549503, Aug2013   12564285,12579005,12589397,12656661,   12669971,12792539,12792897,12853506,   12861697,12891631,12922012,12982278,   13182063, 13204832, 13740457 .
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
  • Descripción del producto
    Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
  • Manufacturer
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538

Manufacturer

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
  • Dirección del fabricante
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA