International safety notice
Technical name: Peripheral Artery Stent
Brazil / Anvisa · BRA · Nov 10, 2017
Key facts
| Title | Technical name: Peripheral Artery Stent |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Innova Over the Wire - Self-expandable Stent Technical name: Peripheral Artery Stent ANVISA registration number: 10341350762 Risk class: III Affected model: Innova 180mm; Affected serial numbers: 17360209; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BOSTON SCIENTIFIC DO BRASIL LTDA CNPJ 01 513 946 0001 14AV DAS NAÇÕES UNIDAS 21476 EDIFÍCIOS P8 P9 E P10 VILA ALMEIDA SÃO PAULO SP FABRICANTE BOSTON SCIENTIFIC CORPORATION ONETWO SCIMED PLACE MAPLE GROVE 553111566 MN EUA ESTADOS UNIDOS EMAIL REGULATORIOBSCICOM |
| Models | 20244724, 18205490, 19984995, 18010625, 19858438, 17515257, 18572704, 18008900, 19786768, 18242554, 17692709, 17631664 and 204 more |
| Date | Nov 10, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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