Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901 Recalled by Volcano Corp Due to Digital IVUS catheter instructions for use ( IFU)...
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 Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Quantity: 14.031 units
Why Was This Recalled?
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
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