Events

Recall of Several batches of expandable metal biliary stents

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 Cook.

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
    2003-09-23
  • 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-plusieurs-lots-d-endoprotheses-biliaires-metalliques-expansibles-par-la-societe-cook
  • 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
    On 05 September, Cook informed AFSSAPS that it was recalling several batches of expandable metal biliary stents. AFSSAPS has not been reported to have a materiovigilance incident concerning these devices in France. The attached letter (23/09/2003) (51 KB) was sent to the 52 user centers, at the following address: intention of local correspondents of materiovigilance September 01, 2003

Device

Several batches of expandable metal biliary stents
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Cook

Manufacturer

Cook