Vascular Solutions—Guardian II Hemostasis Valves: Low Pressure Valve May Not Close Properly
March 16, 2016 | Risk Management News
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In a March 3, 2016, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Vascular Solutions states that the low pressure seal in the above valves may not close properly, which may allow air to be introduced into the device, potentially leading to air embolism. Vascular Solutions states that it has received no reports of adverse events related to this problem. The manufacturer has not confirmed the...