Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Guardian II Hemostasis Valve Recalled by Vascular Solutions, Inc. Due to Vascular Solutions became aware of a potential problem...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vascular Solutions, Inc. directly.
Affected Products
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
Quantity: 5283
Why Was This Recalled?
Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vascular Solutions, Inc.
Vascular Solutions, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report