International safety notice
Alert 2533 (Technovigilance) Cardinal Health do Brasil - Smart Flex Vascular Stent System (5 - 8 Mm) Cracks in the device can result in saline solution leakage.
Brazil / Anvisa · BRA · Apr 6, 2018
Key facts
| Title | Alert 2533 (Technovigilance) Cardinal Health do Brasil - Smart Flex Vascular Stent System (5 - 8 Mm) Cracks in the device can result in saline solution leakage. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: Smart Flex Vascular Stent System ( 5 - 8 Mm) Technical name: Stent for peripheral arteries ANVISA registration number: 81356112255 Risk class: III Affected model: Smart Flex (5-8) Affected serial numbers: 41064; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO CARDINAL HEALTH DO BRASIL CNPJ 19585158000107 RUA CLAUDIO 74 VILA ROMANA CEP 05043000 SÃO PAULO SP TEL 11 987244762 EUGENIASOLOMONCARDINALHEALTHCOM FABRICANTE CORDIS CASHEL CAHIR ROAD CASHEL IRLANDA |
| Models | 41343, 41014, 41118, 41195, 41331, 41109, 41019, 41460, 81356112255, 41304, 41064, 41337 and 15 more |
| Date | Apr 6, 2018 |
| 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