Events

Safety Alert for Trade name: NITINOL CORDIS STENTS Technical name: STENT FOR PERIPHERAL ARTERIES ANVISA registration number: 80145901077 Hazard class: IV Model affected: PC0540XCE; PC0620XCE; PC0630XCE; PC0640XCE; PC0720XCE; PC0730XCE; PC0830XCE; PC0840XCE; PC0920XCE; PC0930XCE; PC0940XCE; PC1020XCE; PC1030XCE; PC1040XCE

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda..

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
    2028
  • Date
    2016-12-13
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Based on recent complaints and subsequent investigation, the company detected that products manufactured between april 27, 2015 and november 22, 2015 are associated with an increase in the frequency of incidents of difficulty of placement and in some cases separation of the rod of the external limb resulting in the impossibility of implanting the stent or in the possibility of partial placement of the stent.
  • Action
    Field Action Code 16000079 triggered under the responsibility of Johnson & Johnson of Brazil Ind. And Com. De Prod. for Health Ltda. Company will collect for further destruction of the product.

Device

Trade name: NITINOL CORDIS STENTS Technical name: STENT FOR PERIPHERAL ARTERIES ANVISA registrati...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.