Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum) Recalled by Volcano Corp Due to Reports of IVUS catheter and guide wire entanglement...
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 Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
Quantity: 233,817
Why Was This Recalled?
Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
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