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-1819-2010
  • 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=91845
  • 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: 9816662 9816664 9825225 9825231 11040448 11041182 11078192 11078420 11093973 11093975 11108899 11110944 11162018 11191140 11191143 11318358 11318707 11412065 11412066 11428368 11428370 11522460 11522461 11559400 11559402 11593826 11593832 11626022 11626025 11659418 11659419 11666874 11666875 11682980 11682981 11722921 11722925 11734945 11756575 11756620 11782914 11782919 11792137 11792360 11825611 11825614 11829608 11829612 11846116 11846118 11902527 11903035 11927690 11927691 11943670 11943683 11973645 11973646 12035398 12035641 12051921 12089897 12089898 12122981 12143396 12143721 12197267 12197268 12205131 12205132 12238955 12238956 12274500 12274503 12314919 12318374 12391990 12398060 12404315 12491821 12500427 12536945 12587048 12603447 12606861 12619342 12635155 12675579 12729536 12743685 12771606 12844953 12888561 12906495 12989820 13016857 13064646 13071656 13075798 13103652 13119112 13173450 13188899 13191108 13218308 13221250 13315928
  • 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 - 10/20 Catalog Number: M00568940. 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