The Minneapolis-based company last month recalled its Guardian II and Guardian II NC valves "due to a risk that air may be introduced into the device which may lead to an air embolism," according to the federal watchdog agency.
The Class I designation is for devices that could cause serious injury or death. The Vascular Solutions valves are used during catheterization procedures to prevent blood loss, according to the FDA.
Vascular Solutions also recalled its SuperCross microcatheter last month, the FDA reported, after discovering "a potential problem with a number of lots … for surface contamination on aged catheters."
VASC shares were trading at $15.88 apiece as of about 11:20 a.m. today, up 1.7%.