Recall of Stent Device Lifestent NT Auto-expandable

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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    The company EDWARDS LIFESCIENCES has withdrawn from the market on 03.05.2005 all batches of references NT186901, NT187901, NT186902, NT 187902, NT356901, NT357901, NT356902, NT357902 of the medical device called Stent Device Lifestent NT Auto-expandable following the highlighting stent deployment problems during the procedure .. The company directly notified the recipients of the incriminated lot with the enclosed message validated by Afssaps (03/05/2005) (89 KB). The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for pharmacy services, health facility managers and local correspondents for material safety for dissemination, where appropriate to the services concerned.