Vascular Solutions—Guardian II Hemostasis Valves: Low Pressure Valve May Not Close Properly

March 16, 2016 | Risk Management News

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​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

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...

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