International safety notice
Alert 2749 (Technovigilance) - CMS Produtos Hospitalares Ltda - AFX AAA Endovascular System - Bifurcated - Possibility of type III endoleaks (leaks).
Brazil / Anvisa · BRA · Dec 26, 2018
Key facts
| Title | Alert 2749 (Technovigilance) - CMS Produtos Hospitalares Ltda - AFX AAA Endovascular System - Bifurcated - Possibility of type III endoleaks (leaks). |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: AFX AAA Endovascular System - Bifurcated Technical Name: Endoprosthesis (Vascular) ANVISA registration number: 80065320085 Risk Class: IV Affected model: See attachment "List of lots and models at risk" Affected serial numbers: See attachment "List of lots and models at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO CMS PRODUTOS HOSPITALARES LTDA CNPJ 3301390000128 RUA 06 C RUA 18 C RUA 19 QD21 LTS1A44 POLO EMPRESARIAL DE GOIÁS APARECIDA DE GOIÂNIA GO TEL 6236255018 EMAIL SORAYACRISTINACMSMEDICALCOMBR FABRICANTE DO PRODUTO ENDOLOGIX INTERNATIONAL HOLDINGS BV 2 MUSICK IRVINE CA 92618 EUA |
| Models | 80065320085 |
| Date | Dec 26, 2018 |
| 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