International safety notice

Implantable Defibrillator.

Brazil / Anvisa · BRA · Feb 23, 2010

Key facts

Title Implantable Defibrillator.
Regulator Brazil / Anvisa
Country BRA
Brand TELIGEN 100 Implantable Cardioverter Defibrillator (Anvisa Registration: 10341350535; affected models: F102; E102); TELIGEN 100 Double Chamber Implantable Cardioverter Defibrillator (Anvisa Registration: 10341350534; affected models: F110; F111; E110; E111); COGNIS 100 Implantable Resynchronizing Defibrillator (Anvisa Registration: 10341350536; affected models: P106; P107; P108; N106; N107; N108; N118; N119).
Manufacturer DETENTOR DO REGISTRO DO PRODUTO NO BRASIL BOSTON SCIENTIFIC DO BRASIL LTDA FABRICANTE BOSTON SCIENTIFIC
Models 10341350535, 10341350534, 10341350536
Date Feb 23, 2010
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices