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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall Volcano Visions PV. 035 Digital IVUS Catheter see related information
Date Initiated by Firm May 13, 2022
Create Date June 29, 2022
Recall Status1 Open3, 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 2		 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 and Original Applicant = VOLCANO CORPORATION
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