International safety notice
Alert 2612 (Technovigilance) - Livanova Brasil LTDA - Perceval S Heart Valve Possibility of stent bending due to oversizing of the Perceval valve.
Brazil / Anvisa · BRA · Jul 12, 2018
Key facts
| Title | Alert 2612 (Technovigilance) - Livanova Brasil LTDA - Perceval S Heart Valve Possibility of stent bending due to oversizing of the Perceval valve. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Perceval S Heart Valve Technical Name: Heart Valve ANVISA registration number: 80483300010 Risk Class: CLASS IV Affected model: PVS21,PVS23,PVS25,PVS27 Affected serial numbers: ICV1208 PVS21 AORTIC HEART VALVE WITHOUT PERCEVAL SUTURE, SIZE ICV1209 PVS23 AORTIC HEART VALVE WITHOUT PERCEVAL SUTURE,SIZE M ICV1210 PVS25 AORTIC HEART VALVE WITHOUT PERCEVAL SUTURE, SIZE L ICV1211 PVC27 AORTIC HEART VALVE WITHOUT PERCEVAL SUTURE,SIZE |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO LIVANOVA BRASIL LTDA CNPJ 45489614000117 RUA LIEGE 54 VILA VERMELHA SÃO PAULO SP TEL 011 29466406 EMAIL ANACLAUDIAMELQUIADESLIVANOVACOM FABRICANTE DO PRODUTO LIVANOVA CANADÁ CORP 5005 NORTH FRASER WAY BURNABY BC V5J 5M1 CANADÁ |
| Models | PVS21, ICV1209, ICV1208, PVS25, ICV1210, PVS23, PVS27, 80483300010, PVC27, ICV1211 |
| Date | Jul 12, 2018 |
| 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