Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 Recalled by BARD PERIPHERAL VASCULAR, INC Due to Complaints of sheath separation, kinking, and/or tip damage...
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 BARD PERIPHERAL VASCULAR, INC directly.
Affected Products
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature
Quantity: 101 units
Why Was This Recalled?
Complaints of sheath separation, kinking, and/or tip damage during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BARD PERIPHERAL VASCULAR, INC
BARD PERIPHERAL VASCULAR, INC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report