International safety notice
LotusTM Valve
Brazil / Anvisa · BRA · Apr 20, 2016
Key facts
| Title | LotusTM Valve |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Transcatheter Aortic Valve Prosthesis Pre-Assembled in the Introduction System LotusTM Valve - ANVISA registration number: 10341350785 - Risk class: IV Maximum Risk - Affected model: All Affected Serial Number: All |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BOSTON SCIENTIFIC DO BRASIL AVENIDA DAS NAÇÕES UNIDAS 21476 SANTO AMARO VILA ALMEIDA SÃO PAULOSP TELEFONE 11 58532544 EMAIL REGULATORIOBSCICOM FABRICANTE BOSTON SCIENTIFIC LIMITED ENDEREÇO BALLYBRIT BUSINESS PARK GALWAY IRLANDA |
| Models | 10341350785 |
| Date | Apr 20, 2016 |
| 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