Vascular Solutions voluntarily recalled specific lots of its Guardian II hemostasis valves, which are used in catheterization procedures.
The FDA classified the action as a Class 1 recall, which affected model numbers 8210 and 8211. The products were manufactured from March 2015 to February 2015 and distributed from April 2015 to February 2016.
Vascular Solutions said the recalled lots may have an increased risk of air leakage that may lead to an air embolism. Although no injuries have been reported related to this issue, the company said the issue could lead to serious injury or death.
Of the 26,550 devices that have been manufactured, 5,283 were distributed in the U.S. The issue may affect approximately 2.4 percent of the recalled devices, according to Vascular Solutions.
The recall does not include the Guardian II NC hemostasis valves.