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-1820-2010
  • 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=91885
  • 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
    Lot Numbers: 9819553 9819558 11057820 11057934 11128481 11128701 11188630 11188633 11254268 11254269 11327810 11327811 11486465 11486466 11591307 11648322 11648324 11687601 11740562 11792533 11828568 11828569 11891601 11933261 11933262 12150199 12295530 12305996 12395349 12463767 12517752 12602517 12619264 12652845 12685511 12687464 12862108 12870991 13074818 13103999 13129113 13138519 13203489
  • 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 - 10/40 Catalog Number: M00568950. 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