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%.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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