Events

Rappel de Radiofrequency Ablation System Pedal Batches Used with EPT-1000 Cardiac Ablation System

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par Boston Scientific.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2009-07-24
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    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
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    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
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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