Alerta De Seguridad para CORDIS EXPANDABLE STENT SYSTEM - registration 80145900749 - Lots: See annex .. http://portal.anvisa.gov.br/wps/wcm/connect/f008ce004a269a4ab06db9aa19e2217c/Alerta_1112_Lotes_afetados.pdf?MOD=AJPERES

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.

Cordis has recently identified that some Cordis SMART® CONTROL® Nitinol Stent System products may have small grooves in the package seal. The potential defect was detected during internal testing on non-production products as part of a development project. Further investigation has identified that there are conditions that may cause a seal groove in a small percentage of the products distributed. The compromised seal is not readily apparent to the naked eye. To date, no claims have been reported and are associated with this defect. This recall is not being performed due to adverse medical events. If there is a groove in the seal, loss of the sterile barrier may occur, resulting in the use of a non-sterile device during a procedure. Contamination may expose the patient to an increased risk of infection. If an infection occurs, medical intervention may be necessary to prevent injury or permanent damage. Infection caused by conventional vascular stents is rare. Patients who have had a stent implanted for less than 30 days should be closely monitored for signs of infection. Cordis has conducted a root cause investigation and will resume distribution of the product as soon as corrective actions and / or inspections are implemented. Anvisa follows this action. No related cases were reported in the National System of Notifications for Sanitary Surveillance - NOTIVISA, until the present moment.