FDA Makes Vascular Solutions' Catheter Valve Recall Class I
The recall of hemostasis valves made by Vascular Solutions is deemed Class I, the most serious category, by the FDA.
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.