Events

Retiro De Equipo (Recall) de Radiofrequency Ablation System Pedal Batches Used with EPT-1000 Cardiac Ablation System

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Boston Scientific.

¿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
  • Fecha
    2009-07-24
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-pedale-pour-systeme-d-ablation-par-radiofrequence-utilisees-avec-le-systeme-d-ablation-cardiaque-ept-1000-boston-scientific
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On 23/07/09, Boston Scientific withdrew from the market the batches mentioned in the attached list (24/07/2009) (24 KB), of the medical device known as a pedal for a radiofrequency ablation system (reference M0048400, sold separately or in kit reference M00448110) used with the EPT-1000 cardiac ablation system, as a result of claims related to these pedals. Examination of these claims revealed that the emission of RF energy can begin without pressing these pedals .. The Boston Scientific company has directly notified the recipients of the offending lots with the message attached (24/07/2009) (39 KB) validated by the Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Read also: Message of 02/10/2009

Device

Radiofrequency Ablation System Pedal Batches Used with EPT-1000 Cardiac Ablation System
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    LAANSM