Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System Recalled by Volcano Corp Due to A limitation in interoperability between the Philips Xper...
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 Corp directly.
Affected Products
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
Quantity: 227 total units - all models
Why Was This Recalled?
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Volcano Corp
Volcano Corp has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report