Events

Retiro De Equipo (Recall) de CURVED TIP WIRE-REINFORCED AORTIC ARCH CANNULA

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
    27386
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-06-26
  • 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
    During inspection of product in its inventory sorin has identified that plastic flash may be present on the tip of the aortic arch cannulae. there is a risk that flash can become detached during cardiac surgery and be released into the patient's blood circulation resulting in the possibility of embolism. to mitigate this hazard sorin is removing these affected aortic arch cannulae from the marketplace and replacing them with new aortic cannulae which have been verified not to contain flash.

Device

CURVED TIP WIRE-REINFORCED AORTIC ARCH CANNULA
  • Modelo / Serial
    Model Catalog: RA-1137 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: NA-1337 (Lot serial: 1700300233); Model Catalog: NA-001TG (Lot serial: 1519500072); Model Catalog: NA-1337 (Lot serial: 1617900116); Model Catalog: NA-1337 (Lot serial: 1611700045); Model Catalog: NA-1337 (Lot serial: 1608800130); Model Catalog: NA-1337 (Lot serial: 1607500029); Model Catalog: NA-1337 (Lot serial: 1530000132); Model Catalog: NA-1337 (Lot serial: 1528600115); Model Catalog: NA-001TG (Lot serial: 1701600204); Model Catalog: NA-001TG (Lot serial: 1634000158); Model Catalog: NA-001TG (Lot serial: 1629800189); Model Catalog: NA-001TG (Lot serial: 1627100070); Model Catalog: NA-001TG (Lot serial: 1623600028); Model Catalog: NA-001TG (Lot serial: 1611700043); Model Catalog: NA-001TG (Lot serial: 1528600113); Model Catalog: NA-1337 (Lot serial: 1620000013)
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    AORTIC ARCH CANNULAE RA-1137;AORTIC ARCH CANNULAE NA-1337;AORTIC ARCH CANNULAE NA-001TG
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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