Medical Device Safety and Recalls: Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect

Vascular Solutions is recalling the Guardian II Hemostasis Valve because of a defect in the low pressure seal, which may allow air bubbles into the device and block blood supply to the heart or blood vessels (air embolism).

The use of affected products may cause serious adverse health consequences, including death.

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