International safety notice
Alert 2714 (Technosurveillance) - Boston - Monorail Carotid Wallstent - EndoVive Standard Balloon Replacement Kit Straight Probe - Victory Guidewire with Hydrophilic Coating - Incorrect labeling of specific lots.
Brazil / Anvisa · BRA · Oct 31, 2018
Key facts
| Title | Alert 2714 (Technosurveillance) - Boston - Monorail Carotid Wallstent - EndoVive Standard Balloon Replacement Kit Straight Probe - Victory Guidewire with Hydrophilic Coating - Incorrect labeling of specific lots. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Monorail Carotid Wallstent; Technical Name: Endoprosthesis (Vascular); ANVISA registration number: 10341350524; Classe de Risco: III; Affected model: H965SCH647120; Affected serial numbers: 21656232; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BOSTON SCIENTIFIC DO BRASIL LTDA CNPJ 01513946000114 AV DAS NAÇÕES UNIDAS 21476 EDIFÍCIOS P8 P9 E P10 VILA ALMEIDA SÃO PAULO SP TEL 11 43808706 EMAIL REGULATORIOBSCICOM FABRICANTE DO PRODUTO BOSTON SCIENTIFIC CORPORATION 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 ESTADOS UNIDOS |
| Models | 10944064, 974101, 10341350838, 21656233, 21656232, H965SCH647120, 974401, M00582040, M00582070, 974201, 10341350524, 10341350719 and 3 more |
| Date | Oct 31, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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