Events

Safety Alert for Taxon on Expression Stent System. ANVISA Registry No. 10341350282

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda/Boston Scientific Corpration.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    778
  • Date
    2004-06-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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