Events

Retiro De Equipo (Recall) de Device Recall Ultraflex tracheobronchial Stent System

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.

¿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
    55784
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1829-2010
  • Fecha de inicio del evento
    2010-05-17
  • Fecha de publicación del evento
    2010-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91895
  • 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
    Prosthesis, tracheal, expandable - Product Code JCT
  • Causa
    Suture related device failures during deployment and repositioning of the stent.
  • Acción
    Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.

Device

Device Recall Ultraflex tracheobronchial Stent System
  • Modelo / Serial
    Catalog Numbers: 9663612 9693003 9693004 9708705 9709379 9763608 9763610 9828124 9828280 11027105 11027229 11053709 11076452 11151542 11171283 11171287 11199522 11203740 11203744 11261000 11261458 11281926 11282276 11539261 11540270 11582708 11582709 11643976 11644160 11688258 11688640 11698615 11698685 11724216 11724217 11772331 11772332 11821584 11821588 11860799 12002002 12002178 12013093 12013094 12018679 12019188 12082197 12082420 12129860 12129863 12169049 12169051 12181375 12181395 12229947 12229950 12293029 12293033 12298605 12298607 12317788 12368065 12388264 12430522 12490847 12495053 12568403 12606620 12624516 12644379 12732528 12754940 12759600 12830237 12896795 12930767 13015806 3019421 13075118 13110000 13125440 13232453 13237201
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - Only US distributed product is affected by recall
  • Descripción del producto
    Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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