Events

Recall of ORBITER ST electrodes;STINGER

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 BARD France.

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
    2003-02-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-d-electrodes-orbiter-st-et-stinger-a-l-initiative-de-la-societe-bard-france
  • 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
    The Agency was informed on 17 January 03 of the following withdrawal. BARD France has withdrawn from the market on January 13, 03 all batches of references 210001 to 210030, 210001M to 210030M, 210001S to 210030S, 210001SM to 210030SM, 320001 to 320009, 320100 of the medical device referred to as ORBITER ST electrodes and STINGER following a risk of tearing the TYVEK side of the bag .. These devices are electrophysiological electrodes for ablation and mapping .. Given the small number of recipients, the company BARD warned them directly.

Device

ORBITER ST electrodes;STINGER
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    BARD France

Manufacturer

BARD France