Events

Recall of POLYSHUNT carotid shunts

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 PEROUSE.

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
    2005-08-22
  • 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-shunts-carotidiens-polyshunt-du-laboratoire-perouse
  • 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 PEROUSE withdrew from the market on the 17/08/05 batches V1874, V1905, V1925, V2047, V2071, V2121, V2162, V2163, V2198 and V2214 of the medical device called carotid shunts POLYSHUNT, reference SC200 and SC300 following 5 reports leakage problems and in particular leaks in the balloon inflation valve which may lead to a longer operating time. The company has directly notified the recipients of the incriminated batches by means of the attached message (22/08 / 2005) (12 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned .. The relevant European Competent Authorities are informed of this measure by the industrialist.

Device

POLYSHUNT carotid shunts
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    PEROUSE

Manufacturer

PEROUSE
  • Source
    LAANSM