Events

Retiro De Equipo (Recall) de Device Recall AFX Endovascular AAA 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 Endologix.

¿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
    76086
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1037-2017
  • Fecha de inicio del evento
    2016-12-27
  • Fecha de publicación del evento
    2017-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152147
  • 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
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Causa
    Endologix updated the instructions for use (ifu) and implemented modifications to the afx endovascular aaa system (afx system).
  • Acción
    Endologix sent a dear physician letter dated June 2, 2015, to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). The letter informs the Physicians of the year's update on the clinical programs and commercial experience (i.e. post-market surveillance). A dear physician letter dated January 2016 was seen to inform them of the enclosed 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The update reports the cumulative clinical data and commercial experience (i.e. post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. A dear physician letter dated December 27, 2016, will be sent to provide important information related to the AFX Endovascular AAA System (AFX System). Endologix is informing the customers of a series of updates to the Instructions for Use (IFU) and modifications to the product. Customers with any questions are instructed to contact their local Endologix representative.

Device

Device Recall AFX Endovascular AAA System
  • Modelo / Serial
    The correction is not lot specific. It applies to AFX procedures conducted after July 2015
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    AFX Endovascular AAA System, Endoleak Type IIIA || Common Name: AFX Bifurcated and Accessory Stent Grafts || Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
  • Manufacturer
    Endologix

Manufacturer

Endologix
  • Dirección del fabricante
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • Empresa matriz del fabricante (2017)
    Endologix Inc.
  • Source
    USFDA