International safety notice
Technical Names: IMPLANT FOR ANEURYSM;
Brazil / Anvisa · BRA · Oct 5, 2016
Key facts
| Title | Technical Names: IMPLANT FOR ANEURYSM; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Five products affected by the Field Action: 1. PIPELINE EMBOLIZATION DEVICE Registration 10349000471 Technical name: ANEURYSM IMPLANT Risk Class IV; 2. ALLIGATOR RECOVERY DEVICE Registration 10349000457 Technical name: DEVICES Risk Class IV; 3. X-CELERATOR HYDROPHILIC GUIDE WIRE Registration 10349000313 Technical name: CARDIOVASCULAR GUIDE WIRE Risk Class II; 4. FLOW ORIENTED MICROCATHETER ULTRAFLOW HPC Registration 10349000461 Technical name: INTRAVASCULAR MICROPERFUSION CATHETER Risk Class IV; 5. MARATHON MICRO CATHETER FLOW DIRECTED Registration 10349000478 Technical name: INTRAVASCULAR MICROPERFUSION CATHETER Risk Class IV; Affected batches: Products manufactured between August 2014 and September 2016 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AUTO SUTURE DO BRASIL LTDA CNPJ 01645409000128 ENDEREÇO AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR 04675010 SÃO PAULOSP TELEFONE DE CONTATO 11 21829200 FABRICANTE MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY IRVINE CA 92618 EUA |
| Models | 10349000313, 10349000478, 10349000461, 10349000457, 10349000471 |
| Date | Oct 5, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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