FDA recall Z-1592-2021

Product

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.

Reason for recall

The firm has received reports of stent migration after implantation

Distribution

Worldwide - US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2021-04-12

Report date

2021-05-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

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