FDA-Device2021-05-26Class I

VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

Boston Scientific Corporation
Hazard

The firm has received reports of stent migration after implantation

Sold states
Worldwide - US Nationwide Distribution
Affected count
34,248 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2021

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