Events

Retiro De Equipo (Recall) de CircuCool Fluid Circulation Pump

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 Boston Scientific 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
    53463
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1156-2010
  • Fecha de inicio del evento
    2009-09-22
  • Fecha de publicación del evento
    2010-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85564
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • Causa
    Product failure-- product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. a component on the circuit board fails unexpectedly because of a power surge, causing a diode to burn out.
  • Acción
    The firm has issued notification letters via Federal express with reply verification tracking forms. A follow up letter and telephone survey as needed will be sent to follow up with non-responders. The firm is asking its consignees to return any recalled product. If there are any questions, please call 1.408.935.4952.

Device

CircuCool Fluid Circulation Pump
  • Modelo / Serial
    Serial numbers:  A9003399 to A9003418, B08003046 to B08003050, B08004180 to B08004209, D08003578 to D08003597, E09002815 to E09002839, G08002514 to G08002533, and K08005118 to K08005137
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    US and to Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
  • Descripción del producto
    CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA. || The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Dirección del fabricante
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • 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
    USFDA