The recall of hemostasis valves made by Vascular Solutions is deemed Class I, the most serious category, by the FDA.
The FDA slapped its most serious designation on the recall of hemostasis valves made by Vascular Solutions (NSDQ:VASC).
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.