Events

Recall of 7F introducers

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
    2005-09-27
  • 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-7f-commercialises-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    The GUIDANT company has withdrawn from the market on September 26, 2005 the batches specified in the annex (26/09/2005) (35 KB) of the medical device called "introducers 7F" reference LLP-7 following a packaging error with 8F dilators. These introducers are intended for the placement of stimulation and defibrillation probes. The company has directly notified the recipients of the incriminated lots with the message attached (26/09/2005) (15 KB) validated by the Afssaps. This information is addressed to the directors of health facilities and to the local correspondents of materiovigilance for dissemination, if necessary to the services concerned. The competent European authorities concerned are informed of this measure by the company GUIDANT.

Device

7F introducers
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM