Events

Retiro De Equipo (Recall) de Boston Scientific brand Matrix2 2D 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-0854-2011
  • 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=95542
  • 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 2D Standard SR Coils.
  • Modelo / Serial
    Material Product Description Catalog # Batch Numbers Expiry Date  Matrix2¿ 2D Standard SR Coils 11286278,11535148,11975068,11975079, Oct2010 through  M003470103SRO 470103-SR 11985922,12156355,12156606,12176009,   10mm x30cm 12330517,12356322,12392934,13602979 Jun2013  M003470308SRO Matrix2¿ 2D Standard SR Coils 470308-SR 11766418,11775113 May2011 through   3mm x8cm May2011   Matrix2¿ 2D Standard SR Coils 11423155,11766419,11836539,11963593, Dec2010 through  M003470410SRO 470410-SR 12156359,12176012,12260125,12358023,   4mm x 10cm 12792923, 13705207 Jul2013  M003470510SRO Matrix2¿ 2D Standard SR Coils 470510-SR 12246984 Nov2011   5mmx10cm   Matrix2¿ 2D Standard SR Coils 11344392,11697463,11873433,11967353, Nov2010 through  M003470515SRO 470515-SR 12156357, 12156624, 12176010, 12259384,   5mmx15cm 12368756,12469532 Feb2012  M003470610SRO Matrix2¿ 2D Standard SR Coils 470610-SR 11800373,12520967 May2011 through   6mmx10cm Mar2012  M003470615SRO Matrix2¿ 2D Standard SR Coils 470615-SR 11377053,11985920,13201010,13220262 Dec2010 through   6mmx15cm Dec2012   Matrix2¿ 20 Standard SR Coils 11414852,11869799,11925610,11967354, Dec2010 through  M003470620SRO 470620-SR 12156352,12156602,12156627,12176016,   6mm x20cm 12261954, 12359026, 13015863, 13115971 Nov2012  M003470715SRO Matrix2¿ 2D Standard SR Coils 470715-SR 11622085,12379812,12853030 Mar2011 through   7mm x 15cm Jul2012  M003470720SRO Matrix2¿ 2D Standard SR Coils 470720-SR 11800378,11984852,13201011,13220457 May2011 through   7mm x20cm Oec2012   Matrix2¿ 2D Standard SR Coils 11869790,11925609,11940380,11992208, Jun2011 through  .J1003470730SRO 470730-SR 12156353,12156605,12176081,12176125,   7mm x30cm 12261953,12311506 Dec2011  M003470820SRO Matrix2¿ 2D Standard SR Coils 470820-SR 11248568,11946183,13201012 Oct2010 through   8mm x20cm Dec2012   Matrix2¿ 2D Standard SR Coils 11552555, 11925611, 11940382, 11975162, Feb2011 through  M003470830SRO 470830-SR 12176014,12261957,12316891,12361241,   8mm x 30cm 12401291 Jan2012  M003470920SRO Matrix2¿ 2D Standard SR Coils 470920-SR 13602873   9mm x20cm Jun2013   Matrix2¿ 2D Standard SR Coils 11869791, 11925176, 11975070, 11975185, Jun2011 through  M003470930SRO 470930-SR 12156358,12156615,12176011,12261956,   9mm x30cm 12370630 Jan2012
  • 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 2D 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