Events

Retiro De Equipo (Recall) de ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY 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
    23038
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-10-06
  • 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
    The manufacturer is updating and consolidating the instructions for use (ifu) for the listed products. included is a new bailout procedure for snapped/broken release wires in the anaconda stent graft system ifu and a new caution in the deployment instructions for the anaconda aaa stent graft system aortic cuff. in addition three current ifus/ifu supplements for the anaconda one-lok aaa stent graft system anaconda iliac stent graft system and anaconda aaa stent graft system aortic cuff have been combined into one main ifu (part no. 301-179).

Device

ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY
  • Modelo / Serial
    Model Catalog: OLB23 (Lot serial: ALL LOTS); Model Catalog: OLB25 (Lot serial: ALL LOTS); Model Catalog: OLB28 (Lot serial: ALL LOTS); Model Catalog: OLB32 (Lot serial: ALL LOTS); Model Catalog: L12X160 (Lot serial: ALL LOTS); Model Catalog: TL1210X080 (Lot serial: ALL LOTS); Model Catalog: L12 X 120 (Lot serial: ALL LOTS); Model Catalog: L12 X 100 (Lot serial: ALL LOTS); Model Catalog: L12 X 080 (Lot serial: ALL LOTS); Model Catalog: L12 X 060 (Lot serial: ALL LOTS); Model Catalog: L17X120 (Lot serial: ALL LOTS); Model Catalog: L16X140 (Lot serial: ALL LOTS); Model Catalog: L16X120 (Lot serial: ALL LOTS); Model Catalog: L15X080 (Lot serial: ALL LOTS); Model Catalog: L13X140 (Lot serial: ALL LOTS); Model Catalog: L13X120 (Lot serial: ALL LOTS); Model Catalog: L13X060 (Lot serial: ALL LOTS); Model Catalog: L12X140 (Lot serial: ALL LOTS); Model Catalog: L12X120 (Lot serial: ALL LOTS); Model Catalog: L12X100 (Lot serial: ALL LOTS); Model Catalog: L12X080 (Lot serial: ALL LOTS); Model Catalog: L12X060 (Lot seria
  • Descripción del producto
    ANACONDA STENT GRAFT SYSTEM ONE-LOK BIFURCATE BODY;ANACONDA STENT GRAFT SYSTEM ILIAC LEG;ANACONDA STENT GRAFT FLARED AND TAPERED LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR);ANACONDA STENT GRAFT ILIAC LEG (FOR ISOLATED ILIAC ANEURYSM REPAIR);ANACONDA STENT GR
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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