Events

Safety Alert for INTRACLUDE INTRA-AORTIC INCLUSION DEVICE. Anvisa Registration n ° 80219050151. Model ICF100.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Edwards Lifescience Comércio de Produtos Ltda; Edwards Lifesciences LLC.

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
    1588
  • Date
    2015-05-29
  • 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
    Users must complete and send information requested by the company in a specific form, available in the Urgent Security Notice. The product is not being collected by the company.
  • Reason
    Possible leakage of the device.
  • Action
    Users should visually examine the device prior to its use and should any damage be identified (tears, tears, signs of bending, etc.) the product should not be used. Review the instructions in the Urgent Security Notice issued by Edwards, available at http://portal.anvisa.gov.br/wps/wcm/connect/d5fb5180488daf34a730effd7a12d53b/ENGLISH+URGENT+POSTURING+POSTURED + M% C3% 89DICO + 1588.pdf? MOD = AJPERES

Device

INTRACLUDE INTRA-AORTIC INCLUSION DEVICE. Anvisa Registration n ° 80219050151. Model ICF100.

Manufacturer

Edwards Lifescience Comércio de Produtos Ltda; Edwards Lifesciences LLC