Events

Recall of Talent AAA aortic stents with the system Xcelerant

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.

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
    2005-02-08
  • 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-d-endoprotheses-aortiques-talent-aaa-de-la-societe-medtronic
  • 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
    Afssaps was informed on February 4, 2005 that the MEDTRONIC company was withdrawing from the market the serial numbers of the references specified in the appendix (04/02/2005) (6 ko), of the medical device called "Talent AAA aortic stents with the system". Xcelerant "following the identification of a number of laying systems with insufficiently welded marker strips, which may lead to detachment of the marker strip. The establishments concerned were notified directly by of the attached message (04/02/2005) (16 KB). The manufacturer will exchange the devices returned later .. The competent European authorities concerned are informed of this measure by the manufacturer .. Serial numbers of the relevant references (04/02/2005) (6 ko Medtronic mail (04 / 02/2005) (16 KB)

Device

Talent AAA aortic stents with the system Xcelerant
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    MEDTRONIC

Manufacturer

MEDTRONIC
  • 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