Events

Alerte De Sécurité sur Taxon on Expression Stent System. ANVISA Registry No. 10341350282

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Boston Scientific do Brasil Ltda/Boston Scientific Corpration.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    778
  • Date
    2004-06-27
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to information from the Boston Scientific Company of Brazil, this recall was initiated in Brazil on July 19, 2004. In order to ensure that health products are safe and effective, ANVISA, through security measures, through the Technovigilance Unit / UTVIG, asked Boston Scientific do Brasil to keep the UTVIG / ANVISA updated regarding the measures that the company has been adopting in a national context, considering that said product is registered in the National Sanitary Surveillance Agency .//// ///////////////////// BRAZIL 08/30/2004 - In compliance with letter no. 87/2004 UTVIG / GGTPS / ANVISA / MS, dated August 06, 2004 , the company informs that there was no case of death or adverse effect related to the voluntary recall motive (non-emptying of the flask of the release system). It also reports that company representatives have personally checked with and removed all stents that were in stock and that the stents will be returned to the distribution center in Quincy, USA. The UTVIG will continue to monitor all actions collection and return of the product in question.
  • Cause
    Some batches may have undergone a narrowing on the lumen which allows the balloon to deflate. (international recall).
  • Action
    Boston Scientific of Brazil reports that Boston Scientific Corpration began on July 2, 2004 in a voluntary recall of 2 batches of TAXUS EXPRESS PACLITAXEL Coronary Artery Stent System after it had identified that some of these batches could have narrowed lumen that allows the balloon to deflate.

Device

Taxon on Expression Stent System. ANVISA Registry No. 10341350282

Manufacturer

Boston Scientific do Brasil Ltda/Boston Scientific Corpration
  • Source
    ANVSANVISA