Events

Recall of Radio Frequency Ablation System Pedal

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Boston Scientific.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2009-10-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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-mise-a-jour-de-la-liste-des-lots-concernes-boston-scientific
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Action
    On 01/10/09, Boston Scientific released an update of the list of lots (02/10/2009) (22 KB) mentioned in the recall message (dated 23/07/09) of the device Medical Equipment called Radio Frequency Ablation System Pedal, part number M0048400 (sold separately or in kit M00448110) used with the EPT-1000 cardiac ablation system. This update follows a failure by the laboratory of certain serial numbers during the establishment of the first list communicated on 23/07/09 during the first rappe. . This withdrawal was made as a result of claims related to these pedals. Examination of these claims had revealed that the emission of RF energy could begin without pressing these pedals. The company Boston Scientific has directly notified the recipients of the incriminated lots with the message attached (02/10/2009) (14 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.

Device

Radio Frequency Ablation System Pedal

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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