Events

Recall of CLARION 1.2®, CLARION CII EAR® and HIRES ™ 90K Implantable Cochlear Stimulators

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 Advanced Bionics.

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
    2004-10-05
  • 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-stimulateurs-cochleaires-implantables-de-la-societe-advanced-bionics
  • 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 October 1, 2004, Advanced Bionics® removed the implanted CLARION 1.2®, CLARION CII EAR® and HIRES ™ 90K Implantable Cochlear Stimulators from the market, following the identification of a few stimulators with moisture levels above tolerances and could lead to malfunctions of these devices .. The company Advanced Bionics® has directly notified the implant centers of the products concerned by this recall using the message attached (05/10/2004) (28 KB) validated by the This message is accompanied by a recommendation Afssaps (01/10/2004) (16 KB). The competent European authorities concerned are informed of this measure by the European representative.

Device

CLARION 1.2®, CLARION CII EAR® and HIRES ™ 90K Implantable Cochlear Stimulators
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Advanced Bionics

Manufacturer

Advanced Bionics
  • Source
    LAANSM