Events

Recall of TAXUS ™ Express2 ™ Monorail®;Express2 ™ Monorail®

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
    2004-07-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/arret-d-utilisation-des-stents-coronaires-express-2-et-taxus-express-2-de-la-societe-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
    In agreement with Afssaps, the BOSTON SCIENTIFIC company requested, on July 20, 2004, the health establishments concerned to stop using the TAXUS ™ Express2 ™ Monorail® stent systems and the Express2 ™ Monorail® coronary stent systems on hold a reminder notification of these devices comprising the precise list of the batches concerned, following several cases of non-deflation of the balloon during the stent placement. All health facilities were recipients of the enclosed alert form (21/07/2004) (86 KB). The other European Competent Authorities have been informed of this measure by the manufacturer. Any incident or any risk of serious incident on these devices must be declared within the framework of materiovigilance to the French Agency for the safety of health products - Department of Vigilance - Fax: 01 55 87 37 0. This information concerns Directors of health establishments, local correspondents of materiovigilance and pharmacists of health establishments using these devices for dissemination to the services concerned.

Device

TAXUS ™ Express2 ™ Monorail®;Express2 ™ Monorail®

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