International safety notice
Alert 2515 (Technovigilance) - Auto Suture do Brasil Ltda - Mindframe Capture LP Revascularization Device Possibility of separation or partial detachment of the device.
Brazil / Anvisa · BRA · Mar 12, 2018
Key facts
| Title | Alert 2515 (Technovigilance) - Auto Suture do Brasil Ltda - Mindframe Capture LP Revascularization Device Possibility of separation or partial detachment of the device. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Mindframe Capture LP Revascularization Device Technical name: Clot Removal Device ANVISA registration number: 10349000580 Risk class: IV Affected model: 300010; Affected serial number: A568589; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AUTO SUTURE DO BRASIL LTDA CNPJ 01645409000128 AV JORNALISTA ROBERTO MARINHO 85 11º ANDAR CEP 04675010 SÃO PAULO SP FABRICANTE MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR TOLEDO WAY 9775 IRVINE CALIFÓRNIA 92618 IRVINE CA 92618 USA CALIFÓRNIA |
| Models | A568589, 10349000580, 300011, A560811, A544383, 300013, 300012, 300010 |
| Date | Mar 12, 2018 |
| 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