Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and Recalled by Volcano Corporation Due to A software issue was discovered where an inaccurate...
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 Volcano Corporation directly.
Affected Products
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature
Quantity: Total of 4007 devices, all models
Why Was This Recalled?
A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Volcano Corporation
Volcano Corporation has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report