Events

Recall of Medtronic guide catheter 110 cm;Medtronic Guide Catheter 100 cm

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 Medtronic France SAS.

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
    2006-04-14
  • 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-catheter-guide-medtronic
  • 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    The company Medtronic France SAS has withdrawn from the market on April 12, 2006, the references and lots, list (12/04/2006) (19 KB) is detailed in the appendix, medical devices called "Medtronic guide catheter 110 cm" and "Medtronic Guide Catheter 100 cm" packaged in 110 cm pockets. This decision follows the detection, during integrity tests, of a risk of micro-holes in the catheter packaging that could create a breach in the sterile barrier of the catheter. The company has directly notified the recipients of the offending lots by means of the attached message (12/04/2006) (17 KB) validated by Afssaps. The relevant European Competent Authorities are informed of this measure by the manufacturer. .. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary to the services concerned.

Device

Medtronic guide catheter 110 cm;Medtronic Guide Catheter 100 cm

Manufacturer

Medtronic France SAS
  • Source
    LAANSM