Events

Recall of INTRO-FLEX

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 Edwards Lifesciences.

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
    2003-06-05
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-certains-lots-de-kits-avec-introducteurs-a-valve-intro-flex-d-edwards-lifesciences
  • 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
    At the request of the AFSSAPS, the company Edwards Lifesciences proceeded on June 4, 2003 with the recall of certain batches of some references of kits with introducers with valve INTRO-FLEX. This medical device is indicated to access the venous system, and to allow the introduction of certain types of catheters (arterial catheter, catheter for infusion) This recall is initiated following materovigilance incidents concerning cracks in the valveTuohy-Borst of the introducer observed after placement in patients .. The attached mail (04/06/2003) (16 KB) was sent to the 159 user centers. This reminder is the subject of information to the competent European authorities (global report N9R11).

Device

INTRO-FLEX

Manufacturer

Edwards Lifesciences