Events

Retiro De Equipo (Recall) de GRAFT ACE PTCA DILATATION CATHETER

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

¿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
    47251
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-03-07
  • 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
    A condition was identified where a small percentage of catheters may have a condition in the inflation lumen that may result in diflation difficulties.

Device

GRAFT ACE PTCA DILATATION CATHETER
  • Modelo / Serial
    Model Catalog: 03647-20 (Lot serial: 3681289); Model Catalog: 02071-01 (Lot serial: 3420668 3482758.); Model Catalog: 03628-20 (Lot serial: 3533336 3640029 3410689); Model Catalog: 02071-01 (Lot serial: 3361428 3479318 3598352); Model Catalog: 03628-20 (Lot serial: 3371541 3439272 3393900); Model Catalog: 02071-01 (Lot serial: 3371541 3439272 3393900); Model Catalog: 03628-20 (Lot serial: 3361428 3479318 3598352); Model Catalog: 03628-20 (Lot serial: 3420668 3482758.); Model Catalog: 02071-01 (Lot serial: 3533336 3640029 3410689)
  • Descripción del producto
    GRAFT ACE 2.0
  • Manufacturer
    BOSTON SCIENTIFIC LTD.

Manufacturer

BOSTON SCIENTIFIC LTD.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HC