Events

Safety Alert for Processed and Preserved Cryogenically Transplantable Human Heart Valve. Nos. Codes: 98-0132HV-01, 98-0132HV-02, 98-0476HV-01, 98-0476HV-02, 98-1302HV-01, 98-1532HV-01, 98-1532HV-02, 99-1311HV- 99-1311HV-02.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LifeNet.

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
    551
  • Date
    2002-03-01
  • 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
    The valves above may have been collected from donors who have not been properly evaluated. the manufacturer initiated a correction by letter dated 16 october 2001.
  • Action
    Make sure you have received the letter dated 16 October 2001 from LifeNet. Identify and isolate any affected product in your inventory. For more information, contact your local LifeNet representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Processed and Preserved Cryogenically Transplantable Human Heart Valve. Nos. Codes: 98-0132HV-01,...
  • Model / Serial
  • Manufacturer
    LifeNet

Manufacturer

LifeNet
  • Source
    ANVSANVISA