Events

Field Safety Notices about Pentaray catheters

According to Agence Fédérale des Médicaments et des Produits de Santé, this field safety notices involved a device in Belgium that was produced by Biosense Webster.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-04-22
  • Event Country
    Belgium
  • Event Source
    AFMPS
  • Event Source URL
    https://www.afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/materiovigilance/fsn
  • Notes / Alerts
    Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, 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 data from the U.S. and Belgium.
  • Extra notes in the data

Device

Pentaray catheters

Manufacturer

Biosense Webster