Vascular Solutions, Inc., is recalling its Guardian II hemostasis valves used in catheterization procedures because they may leak air, which could cause an air embolism, which could lead to serious injury or death.
The nationwide recall involves specific lots of Model Numbers 8210 and 8211 of Guardian II hemostasis valves, and does not include the Guardian II NC hemostasis valves. The affected products were manufactured from March 2015 to February 2016 and distributed from April 2015 to February 2016. The recall affects 26,550 devices, of which 5,283 were distributed in the United States. The condition that led to the recall may affect about 2.4 percent of the recalled devices.
Health care facilities that received the defective hemostasis valves have been notified and instructed to remove the devices from their inventory and return them to Vascular Solutions.
Any adverse events associated with affected Guardian II hemostasis valves should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.