Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SOLOPATH Balloon Expandable TransFemoral System Recalled by Terumo Medical Corporation Due to There is a potential for dislodgement of the...
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 Terumo Medical Corporation directly.
Affected Products
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.
Quantity: 2228
Why Was This Recalled?
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Medical Corporation
Terumo Medical Corporation has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report