International safety notice
Alert 2827 (Technosurveillance) - Edwards - Edwards Sapien 3 - Edwards Commander System / Edwards Sapien 3 - Edwards Commander System - Possibility of balloon rupture during the valve alignment stage.
Brazil / Anvisa · BRA · Mar 21, 2019
Key facts
| Title | Alert 2827 (Technosurveillance) - Edwards - Edwards Sapien 3 - Edwards Commander System / Edwards Sapien 3 - Edwards Commander System - Possibility of balloon rupture during the valve alignment stage. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Edwards Sapien 3 - Edwards Commander System / Edwards Sapien 3 - Sistema Commander Edwards Technical Name: Biological Heart Valve Prosthesis ANVISA registration number: 80219050159 Risk Class: IV Affected model: 9610TF23, 9610TF26, 9610TF29, 9610TF20, S3TF123, S3TF126, S3TF129, S3TF120 Affected serial numbers: All batches of products with models 9610TF23, 9610TF26, 9610TF239, 9610TF20, S3TF123, S3TF126, S3TF129, S3TF120 are affected. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICOCIRÚRGICOS LTDA CNPJ 05944604000100 RUA VERBO DIVINO 1547 1º ANDAR CJS 101102 SÃO PAULO SÃO PAULO TEL 1155675233 EMAIL CORABELZONIEDWARDSCOM FABRICANTE DO PRODUTO EDWARDS LIFESCIENCES LLC ONE EDWARDS WAY IRVINE CALIFORNIA 926145686 ESTADOS UNIDOS |
| Models | 80219050159, S3TF123, 9610TF26, 9610TF23, 9610TF239, 9610TF20, S3TF126, S3TF129, 9610TF29, S3TF120 |
| Date | Mar 21, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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