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-1826-2010
  • 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=91892
  • 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: 9703315 9714662 9714664 9821713 9821714 11037142 11037488 11065953 11067756 11085020 11107374 11107379 11119412 11120147 11187951 11187955 11329333 11330281 11356485 11356486 11393422 11393424 11458543 11459948 11506685 11506686 11541160 11541162 11578196 11578520 11597599 11597682 11610973 11610975 11678541 11678549 11696764 11696767 11753789 11753920 11787647 11787649 11821207 11883892 11883922   11888074 11888321 11895796 11895845 11907389 11907390 11963638 11964061 12033762 12033763 12101027 12101029 12113346 12113347 12140516 12140517 12150322 12150326 12217034 12217323 12225070 12225213 12251730 12251733 12284357 12312841 12329238 12334705 12377720 12409688 12414272 12426158 12552665 12571603 12620323 12643126 12654667 12707139 12739832 12746937 12778328 12831272 12831461 12851487 12868350   12897747 12933682 12975410 12989155 12992395 12992922 13074849 13149043 13167175 13171927 13204146 13218651 13220534
  • 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. Covered - 10/30/15 Catalog Number: M00569050. 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