Events

Retiro De Equipo (Recall) de Device Recall Wingspan 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
    56716
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0627-2011
  • Fecha de inicio del evento
    2010-08-25
  • Fecha de publicación del evento
    2010-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94345
  • 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
    Intracranial Neurovascular Stent - Product Code NJE
  • Causa
    Products may not meet radial force specifications.
  • Acción
    Recall initiated August 25, 2010. "Urgent Medical Device Recall - Immediate Action Required" notifications, dated 25 August 2010, were delivered by FedEx where possible, and by personal delivery assigned to sales representatives. The letter identified the affected product and the reason for recall. The letter stated that further distribution or use of any remaining product should cease immediately. Customers were asked to read the enclosed instructions and told that their local Sales Rep could answer any questions that they may have regarding the recall.

Device

Device Recall Wingspan Stent System
  • Modelo / Serial
    Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    HDE
  • ¿Implante?
    Yes
  • Distribución
    International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.
  • Descripción del producto
    Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA || Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 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