Events

Recall of Omnilink .018 and .035 Peripheral 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 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
    2005-08-12
  • 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-des-endoprotheses-vasculaires-peripheriques-omnilink--018-et--035-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
    On August 11, 2005, GUIDANT France withdrew from the market all lots currently on the market, medical devices known as Omnilink .018 and .035 peripheral vascular endoprostheses following the receipt of several reports mentioning stents insufficiently fixed on the market. installation device or having migrated during the procedure .. The company has directly notified the recipients of the incriminated lots with the message attached (11/08/2005) (55 KB) validated by Afssaps. information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer.

Device

Omnilink .018 and .035 Peripheral Stents
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM