Events

Retiro De Equipo (Recall) de Boston Scientific brand Matrix 2D Soft 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-0856-2011
  • 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=96008
  • 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 Matrix 2D Soft SR Coils.
  • Modelo / Serial
    Material Product Description Catalog # Batch Numbers Expiry Date   M003471304SRO Matrix2¿ 2D Soft SR Coils 3mm 471304-SR 11391991,11697446,11721433,11775115, Dec2010 through   x4cm 12579020 Mar2012  M003471306SRO Matrix2¿ 2D Soft SR Coils 3mm 471306-SR 11498868,11775116,12194493,12385403, Jan2011 through   x6cm 12520966, 12861735 Jul2012  M003471308SRO Matrix2¿ 2D Soft SR Coils 3mm 471308-SR 11481348,11792449,11820171,12401292, Jan2011 through   x8cm 12514514, 12792920 Jun2012  M003471310SRO Matrix2¿ 2D Soft SR Coils 3mm 471310-SR 11342011,11634830,12390151,12439220, Nov2010 through   x 10cm 12982264 Sep2012  M003471406SRO Matrix2¿ 2D Soft SR Coils 4mm 471406-SR 11502704,11641203,12081496,12474445, Jan2011 through   x6cm 12795286 Jun2012   11622088,11718835,11869785,11925599,   11940238,11985921,11992220,12156354,  M003471408SRO Matrix2¿ 2D Soft SR Coils 4mm 471408-SR 12156603,12176007,12176017,12194725, Mar2011 through   x8cm 12295449,12356324,12356325,12514591, Dec2012   12636738,12748405,12748465,12845925,   12891630,12906595,13200124   Matrix2¿ 2D Soft SR Coils 4mm 11310206,11552557,11766672,12119904, Oct2010 through  M003471410SRO 471410-SR 12161473,12409142,12439231,12791147,   x 10cm 12792538 Jun2012  M003471508SRO Matrix2¿ 2D Soft SR Coils 5mm 471508-SR 11622083,12176098,12229542,12721621, Mar2011 through   x8cm 13020445 Sep2012   11800192,11869788,11925606,11940381,   11963592,11996801,12155987,12156601,  M003471510SRO Matrix2¿ 2D Soft SR Coils 5mm 471510-SR 12176008,12194708,12314468,12330568, May2011 through   x 10cm 12368755,12409141,12514589,12636752, Jun2013   12669963,12670049,12703140,12753166,   12792908,12861687,12981682,13603463  M003471515SRO Matrix2¿ 2D Soft SR Coils 5mm 471515-SR 11384554,11641206,12176118,12182654, Dec2010 through   x 15cm 12246986,12649894,13020067 Sep2012   11384857,11748388,11925177,11940389,  M003471610SRO Matrix2¿ 2D Soft SR Coils 6mm 471610-SR 11967352,12112307,12155988,12176015, Dec2010 through   x 10cm 12330561,12356327,12374220,12847321, Aug2012   12947525,12971457  M003471615SRO Matrix2¿ 2D Soft SR Coils 6mm 471615-SR 11532410,11800196 Feb2011 through   x 15cm May2011  1003471620SRO Matrix2¿ 2D Soft SR Coils 6mm 471620-SR 11373732,11634833,12261958,12649895, Dec2010 through   x20cm 12792911 Jun2012  M003471710SRO Matrix2¿ 2D Soft SR Coils 7mm 471710-SR 12499178,13108359 Feb2012 through   x 10cm Oct2012  M003471715SRO Matrix2¿ 2D Soft SR Coils 7mm 471715-SR 11820280,12229546,12249163 May2011 through   x 15cm Nov2011  M003471720SRO Matrix2¿ 2D Soft SR Coils 7mm 471720-SR 11622084,11938494,12246985,12579366 Mar2011 through   x20cm Mar2012  M003471820SRO Matrix2¿ 2D Soft SR Coils 8mm 471820-SR 11622082,11766666 Mar2011 through   x20cm May2011  M003471830SRO Matrix2¿ 2D Soft SR Coils 8mm 471830-SR 11697466,12229584 Apr2011 through   x30cm Nov2011
  • 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 Matrix 2D Soft 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