Events

Safety Alert for Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Risk classification IV-Maximum Risk. Lots affected: 172 lots (description of the attached lots, next to the letter to the clients)

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; Cordis Corporation.

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
    1910
  • Date
    2016-06-14
  • 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
    Recommendations to users and patients: Check the inventory immediately to confirm if you have any of the affected lot units. Identify and separate the units of the affected lots so as to ensure that the affected product is not used. Check all the places of storage and use.
  • 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. considering the risk analysis of the product, the potential impact of the impossibility of implanting the stent or the possibility of partially implanting the stent include a delay during the procedure while a replacement device is prepared; vessel injuries requiring unplanned percutaneous or surgical intervention to prevent injury or permanent disability; or in more severe cases, transient ischemic attack or stroke.
  • Action
    Action code 16000079. Letter to customers //// Collection.

Device

Commercial Name: NITINOL CORDIS STENTS (Stent for peripheral arteries), Registry 80145901077. Ris...

Manufacturer

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