The U.S. Food and Drug Administration (FDA) has issued a recall for Vascular Solutions, Inc.’s Guardian II Hemostasis Valves because of increased risk of air leakage that may cause an air embolism. The valves, which are used in catheterization procedures, were initially manufactured between March 2015 and February 2016. Vascular Solutions Inc., notes that the recall only includes the Guardian II hemostasis valves, not the Guardian II NC ones.

According to the FDA, “health care facilities that have the affected Guardian II hemostasis valves (model numbers 8210 and 8211) should remove the products from their inventory and return them to Vascular Solutions.”

Read the FDA announcement.

Clinical Topics: Vascular Medicine, Sleep Apnea

Keywords: Catheterization, Embolism, Air, Hemostasis, Mental Recall, United States Food and Drug Administration

< Back to Listings