Events

Retiro De Equipo (Recall) de Device Recall Powerlink (R) System with IntuiTrak Delivery 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 Inc.

¿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
    53983
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0594-2010
  • Fecha de inicio del evento
    2009-11-25
  • Fecha de publicación del evento
    2010-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86997
  • 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
    Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Causa
    This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. if this occurs, treatment may be delayed or interrupted. the firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health.
  • Acción
    The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.

Device

Device Recall Powerlink (R) System with IntuiTrak Delivery System
  • Modelo / Serial
    MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
  • Descripción del producto
    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc
  • Dirección del fabricante
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA