International safety notice
Alert 2837 (Technosurveillance) - Edwards Lifesciences Comércio de Produtos Médico-Cirúrgicos Ltda.
Brazil / Anvisa · BRA · Apr 5, 2019
Key facts
| Title | Alert 2837 (Technosurveillance) - Edwards Lifesciences Comércio de Produtos Médico-Cirúrgicos Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Fogarty Catheter for Edwards Atrioseptostomy Technical Name: Catheters ANVISA registration number: 80219050002 Risk Class: CLASS III Affected model: 830705F Affected serial numbers: 61252471, 61252230, 61361008, 61369040, 61444420, 61516362, 61542459, 61731942, 58828227, 58897437 |
| 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 | 61542459, 61731942, 61252471, 61516362, 61369040, 61252230, 80219050002, 830705F, 58897437, 61444420, 58828227, 61361008 |
| Date | Apr 5, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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