TACHYARRITMIA RIATA ELECTRODE (1580/1581); RADIANT TRANSCENDANT TACHYARRHYTHMIA ELECTRODE (1570/1571); CABLE ELECTRODE OF TRANSIENTAL TRAQUIARRITMIA RIATA (7000, 7001 and 7002); CABO ELETRODO DE TACHIARRITMIA TRANSVENOSO RIATA (1940/1941); CABLE ELETRODO DE TACHIARRITMIA TRANSVENOSO RIATA 1942 (1942); CABLE ELECTRODE OF TACHYARRHYTHMIA TRANSVENOSO RIATA ST (7040/7041); and CABLE ELETRODE OF TRANSVENIOUS TACHYARRHYTHMIA RIATA ST 7042 (ST 7042). Registers in Anvisa: 10332340094 (discontinued on 02/25/2008), 10332340106 (12/29/2008), 10332340172, 10332340188, 10332340189, 10332340191 and 10332340201.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA