Events

Recall of Unshielded Biliary Endoprostheses (SHS)

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 LIFE PARTNERS EUROPE.

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
    2009-12-04
  • 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-lots-d-endoprotheses-biliaires-couvertes-shs-et-non-couvertes-shcl-par-life-parners-europe
  • 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 02/12/09, LIFE PARTNERS EUROPE removed from the market the batches of the references (listed in the mail destined for these customers) of medical devices called "Unshielded Biliary Endoprostheses (SHS)" and "Biliary Endoprostheses Covered with Lasso". -Hanarostent (SHCL) "following a defect that may occur during the placement of prostheses. Concerning the SHS reference, this is a blockage of the introducer of the stent and concerning the reference SHCL, it is a poor deployment of the prostheses at the level of the flare which carries the lasso: the Silicone blanket and lasso remain agglomerated. The company LIFE PARTNERS EUROPE has directly notified the recipients of the offending lots with the message attached (04/12/2009) (109 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer. Read also Additional information from 14/01/2010

Device

Unshielded Biliary Endoprostheses (SHS)

Manufacturer

LIFE PARTNERS EUROPE