PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: May 26, 2021 Initiated: April 12, 2021 #Z-1591-2021

Product Description

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

Details

Units Affected
550 units
Distribution
Worldwide - US Nationwide Distribution
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.. Recalled by Boston Scientific Corporation. Units affected: 550 units.
Why was this product recalled?
The firm has received reports of stent migration after implantation
Which agency issued this recall?
This recall was issued by the FDA Devices on May 26, 2021. Severity: Critical. Recall number: Z-1591-2021.