Events

Recall of Intrathecal catheters model 8731

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 Medtronic France.

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
    2006-08-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-des-catheters-intrathecaux-modele-8731-de-la-societe-medtronic-france
  • 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
    Medtronic France withdrew from the market on August 3, 2006 all batches whose expiry date is before or after August 28, 2006 of the medical device called "intrathecal catheter model 8731" which have not been implanted, following 22 reports reporting a detachment of the platinum iridium end of the catheter under the action of the guide wire during implantation under medical supervision. The company has directly notified the recipients of the incriminated lots with the attached message (04/08/2006) (65 KB) validated by the Afssaps. This information is addressed to the directors of health facilities and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Intrathecal catheters model 8731

Manufacturer

Medtronic France
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    LAANSM