Events

Recall of Probe introducers distributed by GUIDANT

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
    2005-06-24
  • 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-introducteurs-de-sondes-distribues-par-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
    The GUIDANT company has withdrawn from the market on June 20, 2005 the references and batches specified in the appendix of the medical devices called introducers (packaged under the GUIDANT or GUIDANT OSCOR brand) and provided for the introduction by venous approach of cardiac stimulation probes, in particular, difficulties encountered during the peeling of the introducer sheath. This recall follows a request from B.Braun Inc., the supplier of these introducers. The company has directly notified the recipients of the incriminated lots with the message attached (20/06/2005) (18 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned.

Device

Probe introducers distributed by GUIDANT
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM