Volcano Corp recalls Volcano Visions Digital IVUS Catheter: PV.014P (Platinum)

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"

On 6/13/2025, correction notices were mailed to customers who were asked to do the following: As per standard practice, take precautions when advancing or removing a catheter in complex vessel anatomies. Do not force a catheter into a narrow vessel or tight stenosis. Be aware that vessel calcification, tortuosity, and untreated vessel spasm are key components of complex vascular anatomy. If the initial guidewire faces resistance or requires further manipulation, consider this to be an indicator of complex patient anatomy. The Instructions for Use currently contains the following related precautions for the user: "Do not advance the guide wire against significant resistance. If binding occurs between the catheter and the guide wire while inside the patient, CAREFULLY REMOVE BOTH the wire and catheter and do not use. If binding occurs outside of the patient, remove the catheter and do not use." Using a long radial sheath avoids this issue by preventing the catheter and guidewire from getting entangled within the sheath. The Instructions for Use highlights the minimum sheath/guide catheter Inner Diameter which does not prevent such complications; therefore, a new precaution will be added to the Instructions for Use: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire." If you need any further information or support concerning this issue, please contact your local Philips representative or Philips IGTD Customer Service: Phone: 1-800-722-9377, Option 1 Email: IGTD.CustomerInquiry@philips.com Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST

• FDA enforcement recordOfficial FDA database entry for Z-2221-2025
• FDA 510(k) clearance · K150442The device's official FDA premarket clearance record
• FDA 510(k) clearance · K152829The device's official FDA premarket clearance record
• FDA device classification · OBJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Volcano CorpSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.