International safety notice
Technical name: Implantable Cardioverter and Defibrillator
Brazil / Anvisa · BRA · Jul 6, 2017
Key facts
| Title | Technical name: Implantable Cardioverter and Defibrillator |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: S-ICD Pulse Generator; Technical name: Implantable Cardioverter and Defibrillator ANVISA registration number: 10341350828 Risk class: IV Affected model: A209, A219 and 1010 Affected serial numbers: 119691, 119606, 119566, 118807, 118834, 119432, 119057, 118820, 117674, 115213, 115422, 115071, 115119, 116516, 112 631, 119489, 115442, 119531, 119495, 120089, 119852, 119893, 119923 , 120009, 120040, 120076, 120217, 120479, 120485, 120493, 120576, 102588, 101736, 119845, 119802, 119721, 119587, 116882. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NOME DO IMPORTADOR E DISTRIBUIDOR BOSTON SCIENTIFIC DO BRASIL LTDACNPJ 01513946000114 ENDEREÇO AV DAS NAÇÕES UNIDAS 21476 EDIFÍCIOS P8 P9 E P10 VILA ALMEIDA TELEFONE 11 43808706 FABRICANTE BOSTON SCIENTIFIC LIMITED ENDEREÇO CASHEL ROAD CLONMEL CO TIPPERARY |
| Models | 102588, 116516, 115213, 120479, 119852, 120009, 120040, 112631, 120089, 119691, 118834, 119893 and 27 more |
| Date | Jul 6, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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