Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Guardian II Hemostasis Valve Recalled by Vascular Solutions, Inc. Due to Vascular Solutions, Inc., became aware of a potential...
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, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Quantity: 3500 units
Why Was This Recalled?
Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
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