Alerta De Seguridad para Taxon on Expression Stent System. ANVISA Registry No. 10341350282

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.

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.