FDA: Vascular Solutions recalls Guardian II hemostasis valves

Editor's Note

The Food and Drug Administration (FDA) on April 11 announced the recall by Vascular Solutions, Inc (Minneapolis, Minnesota), of specific lots of Guardian II hemostasis valves used in catheterization procedures.

The recall was initiated because of an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.

The recalled products are specific lots of Model Numbers 8210 and 8211, which were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016. 

Posted 04/11/2016] AUDIENCE: Risk Manager, Surgery ISSUE: Vascular Solutions, Inc. initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. The recalled products are specific lots of Model Numbers 8210 and 8211. The products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.