Events

Retiro De Equipo (Recall) de ANACONDA STENT GRAFT SYSTEM - FLARED LEG WITH DELIVERY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LIVANOVA CANADA CORP..

¿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
    45093
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Vascutek has recived two complaints whereby a small section of the delivery system sheath became detached from the collar during deployment of the anaconda longer leg iliac stent device from the delivery system. should this occur users should refer to the bailout procedure in the instructions for use (ifu) to complete the deployment.

Device

ANACONDA STENT GRAFT SYSTEM - FLARED LEG WITH DELIVERY
  • Modelo / Serial
    Model Catalog: FL1223X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1221X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1221X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1219X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1219X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1217X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1217X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1215X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1215X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1213X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1213X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: TL1210X170 (Lot serial: 2002380298); Model Catalog: TL1210X150 (Lot serial: 2002380298); Model Catalog: TL1210X170 (Lot serial: 2002233717); Model Catalog: TL1210X150 (Lot serial: 2002233717); Model Catalog: TL1210X170 (Lot serial: 2002224604); Model Catalog: TL1210X150 (Lot serial: 200222460
  • Descripción del producto
    ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (FLARED);ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (TAPERED);ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (STRAIGHT)
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    HC