Guardian II Hemostasis Valve Recall Issued For Air Embolism Risk

Federal health officials have ordered hospitals to remove several lots of Guardian II hemostasis valves from their inventory because they could cause patients to suffer a deadly air embolism.

The FDA announced this week that it is designating a Guardian II Hemostasis Valve recall as a Class I medical device recall, after the manufacturer sent out an urgent recall letter to customers in late February.

The class I designation is the most serious type of medical device recall, and means the FDA believes there is a reasonable probability that the defective medical device will cause serious adverse health effects, injury or death.

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Hemostasis valves are used during the catheterization process to prevent blood loss. According to the FDA, some of the Guardian II and Guardian II NC hemostasis valves can allow air into the system, which could cause an air embolism. Neither the FDA nor the manufacturer, Vascular Solutions, have indicated whether the valves have been linked to any reports of injury or death.

Air embolisms occur when a bubble of gas gets into the blood stream. If a large enough bubble gets to the heart it could stop blood flow and be fatal. The bubbles are even more dangerous if they get into an artery and can cause a stroke, heart attack, or death.

The recall affects the Guardian II and Guardian II NC Hemostasis Valves with model numbers 8210, 821, 8215, and 8216. A complete list of affected lot numbers has been sent to all Vascular Solutions customers.

In its recall letter, Vascular Solutions called for all hospitals to immediately remove the valves from their inventory and secure them. Consumers with questions can call the company at (888) 240-6001 or send an email to customerservice@vasc.com.

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