> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Vascular Solutions Recalls Guardian II Hemostasis Valves
- URL: https://www.fdaweb.com/vascular-solutions-recalls-guardian-ii-hemostasis-valves/
- Published: 2016-04-11T12:00:00.000Z
- Updated: 2026-09-14T20:53:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135319

Vascular Solutions has begun a recall of its Guardian II hemostasis valves (Model Numbers 8210 and 8211) used in catheterization procedures because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. The affected products were manufactured from 3/2015 to 2/2016\. Healthcare facilities that have the recalled products should remove them from their inventory and return them to the company, according to a [recall notice](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm495409.htm?ref=fdaweb.com).

Vascular Solutions and its CEO **Howard Root** are better known for being found not guilty earlier this year on all federal charges concerning alleged off-label promotions of the Vari-Lase Short Kit. This was a significant loss for the government and FDA because it was hailed as an escalation in enforcement for holding company executives responsible for corporate wrongdoing. The case stemmed from a 2014 Department of Justice [indictment](http://www.fdalawblog.net/VSI%20Indictment%20%2800033302%29.pdf?ref=fdaweb.com) charging Vascular Solutions and Root with selling unapproved medical devices and conspiring to defraud the government by concealing the allegedly illegal sales activity. The government charged Root and the company with one count each of conspiracy and eight counts of introducing adulterated and misbranded medical devices into interstate commerce.