Events

Recall of Solysafe septal occluder

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 Swissimplant.

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
    2010-09-09
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/solysafe-septal-occluder-swissimplant-retrait-de-dispositifs
  • 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
    Afssaps was informed on 02/09/10 of the implementation of a product recall carried out by Swissimplant. Users of this device had already received the enclosed letters. (09/09/2010) (2660 KB) Read more Solysafe septal occluder - Swissimplant - Safety information (26/10/2010)

Device

Solysafe septal occluder
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Swissimplant

Manufacturer

Swissimplant