Class 2 Device Recall Visions PV .014P RX Digital IVUS Catheter, Visions PV .018 Digital IVUS Catheter

• Date Initiated by Firm: June 13, 2025
• Date Posted: July 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2221-2025
• Recall Event ID: 97192
• 510(K)Number: K150442 K152829
• Product Classification: Catheter, ultrasound, intravascular - Product Code OBJ
• Product: 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.
• Code Information: UDI-DI: 00845225002848, 00184360000037. Instructions for use: 300004875732_A Revision Date: 03/2021, 300004410212.A Release Date: 03/2021
• FEI Number: 3008363989
• Recalling Firm/ Manufacturer: Volcano Corp; 3721 Valley Centre Dr Ste 500; San Diego CA 92130-3328
• For Additional Information Contact: Michelle Thompson; 425-908-2642
• Manufacturer Reason for Recall: 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"
• Action: 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
• Quantity in Commerce: 233,817
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of BR, PL, SK, IT, DK, DE, GB, AT, KW, CR, ES, NL, LV, MT, IE, CH, ZA, RO, FI, PR, FR, CA, PA, IL, SE, PT, HR, GR, NZ, HK, TW, MY, TH, MX, AR, PE, AE, BG, AU, JP, ID, RS, CO, SG, BE.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OBJ