FDA Issues Class 1 Recall of Hemostasis Valves

The FDA issued a Class I recall of Guardian II and Guardian II NC Hemostasis Valves (Model Numbers 8210, 8211, 8215, 8216) manufactured by Vascular Solutions Inc. The Agency notified health care professionals that serious adverse health consequences, including death, could occur due to the potential for an air embolism. Products that were manufactured and distributed between February 2012 and February 2013 are affected. Ahead of the FDA recall, Vascular Solutions sent an "Urgent Medical Device Recall" notice to its customers warning about the risk. Read the FDA alert.

Clinical Topics: Vascular Medicine

Keywords: Risk, Death, Embolism, Air, Hemostasis, Medical Device Recalls

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