Events

Recall of CAROTID WALLSTENT OTW;EASY WALLSTENT

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 Boston Scientific.

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
    2004-01-12
  • 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-d-endoprotheses-carotid-wallstent-otw-et-easy-wallstent-boston-scientific
  • 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 of two product recalls carried out on December 17 and 18, 2003 by Boston Scientific. The product recall on December 17, 2003 is for all batches of all CAROTID WALLSTENT OTW carotid stent references. It follows the occurrence, in Europe, of 2 cases of detachment of the tip of the stent delivery system. No incidents have been reported in France. The recall on December 18, 2003 is for all lots of all EASY WALLSTENT vascular stent references. It follows the occurrence, worldwide, of 15 cases of detachment of the tip of the stent delivery system. No incidents have been reported in France. The health institutions concerned by these reminders received the enclosed letters (12/01/2004) (20 KB). The other competent European authorities have been informed of these measures by the manufacturer.

Device

CAROTID WALLSTENT OTW;EASY WALLSTENT

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    LAANSM