FDA recall Z-1591-2021

Boston Scientific Corporation · Class I · device

Product

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

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-1591-2021