Events

Safety Alert for Several. Introductory Kit 7F. Lot: 185BIO7, 88BIO07 /// Introductory Kit 10F. Lot: 2628B, 2629B, 2637B, 2642B./// Introductory Kit 11F. Lot: 1670C./// Pulsar Pulse Pulsar VDD 870. Series: 207657./// Pacemaker Insignia Model 1198. Series: 102825./// Pacemaker Insignia Model 1298. Series: 151286./// Endocardial Electrode Model 4035. Series: 311672./// Endocardial Electrode Model 4244. Series: 429970, 432590./// Endocardial Electrode Model 4245. Series: 414359, 414402./// Endocardial Electrode Model 4342. Series: 201121./// Fineline Electrode Model 4459. Series: 309880./// Fineline Electrode Model 4473. Series: 318385./// Fineline Electrode Model: 4474. Series: 307118./// Adapter LV-1 IS-1. Lot: 101120, 300661./// Scheduler Model 2920. Series: 30587.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GUIDANT DO BRASIL 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
    750
  • Date
    2003-10-30
  • 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
    considering the provisions of Article 6 of Law No. 9,782, of January 26, 1999; considering the provisions of Article 6, Item I, and Article 12, paragraph 3, Section III, of Law No. 8,078, of September 11, 1990; considering the Theft Communication of Products for Health of the company GUIDANT DO BRASIL LTDA., File No. 213437 / 03-3; Considering the Boletim de Occurência nº 7844/2003, issued by the 96th Police Station of the Civil Police of the State of São Paulo;
  • Reason
    Stolen health products.
  • Action
    To determine, as a measure of health interest, the seizure, throughout the national territory, of the products listed below, as they are full batches of stolen health products.

Device

Several. Introductory Kit 7F. Lot: 185BIO7, 88BIO07 /// Introductory Kit 10F. Lot: 2628B, 2629B, ...

Manufacturer

GUIDANT DO BRASIL LTDA
  • Source
    ANVSANVISA