Events

Recall of VOYAGER RX coronary balloon catheters

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 Guidant.

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
    2005-01-31
  • 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-de-catheters-a-ballonnet-coronaire-voyager-rx-de-guidant
  • 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    On January 28, 2005, the company GUIDANT has withdrawn from the market all batches of the references listed in the table in annex (28/01/2005) (6 ko) of the medical device called "VOYAGER RX coronary balloon catheters" of balloon diameters from 1.5 to 3.5 mm due to the risk of leakage at the outlet of the metal guide .. The affected recipients are notified directly by the manufacturer with the enclosed message validated (28/01/2005) ( 13 kb) by the Afssaps. This information is addressed to the directors, the local correspondents of materiovigilance and the pharmacists for diffusion if necessary to all the services concerned. The competent European authorities concerned are informed of this measure by the manufacturer. .. Reminder message (28/01/2005) (13 KB List of references concerned (28/01/2005) (6 KB)

Device

VOYAGER RX coronary balloon catheters
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM