Class 3 Device Recall Volcano Visions PV. 035 Digital IVUS Catheter

• Date Initiated by Firm: May 13, 2022
• Create Date: June 29, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1301-2022
• Recall Event ID: 90252
• 510(K)Number: K121273
• Product Classification: Catheter, ultrasound, intravascular - Product Code OBJ
• Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
• Code Information: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329
• Recalling Firm/ Manufacturer: Volcano Corp; 3721 Valley Centre Dr Ste 500; San Diego CA 92130-3328
• For Additional Information Contact: Emily Dentler; 619-380-1318
• Manufacturer Reason for Recall: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
• FDA Determined Cause: Process control
• Action: On May 25, 2022, Philips issued a "Urgent Medical Device Correction" notification. Phillips asked customers to take the following actions: 1. Philips recommends reviewing the enclosed compliant Instructions for Use, in Appendix A, before proceeding as normal. 2. As per standard practice, precaution should always be used when advancing or removing a catheter in complex vessel anatomies, such as not forcing a catheter into a narrow vessel or a tight stenosis. Vessel calcification, tortuosity and pre-existing untreated vessel spasm are key components to any complex vascular anatomy. Additionally, if the initial guidewire faces resistance or requires further manipulations, please use this as an indicator of complex patient anatomy. 3. Philips is providing this Urgent Medical Device Correction letter to affected customers and recommends forwarding this notification to all staff who need to be aware within your organization or to any organization where the potentially affected devices may have been transferred. 4. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form within 30 days upon receipt of this notice to Email: igtdc.r@philips.com
• Quantity in Commerce: 14.031 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.
• 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.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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