{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "193882", "product_res_number": "Z-1301-2022", "event_date_initiated": "2022-05-13", "event_date_created": "2022-06-29", "recall_status": "Open, Classified", "res_event_number": "90252", "product_code": "OBJ", "k_numbers": [ "K121273" ], "product_description": "Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797", "code_info": "All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329", "firm_fei_number": "3008363989", "recalling_firm": "Volcano Corp", "address_1": "3721 Valley Centre Dr Ste 500 3721 Valley Centre Dr", "address_2": "Ste 500", "city": "San Diego", "state": "CA", "postal_code": "92130-3328", "additional_info_contact": "Emily Dentler\n619-380-1318", "reason_for_recall": "Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications", "root_cause_description": "Process control", "action": "On May 25, 2022, Philips issued a \"Urgent Medical Device Correction\" notification. Phillips asked customers to take the following actions:\n\n1. Philips recommends reviewing the enclosed compliant Instructions for Use, in Appendix A, before proceeding as normal. \n\n2. 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.\n\n3. 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. \n\n4. 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", "product_quantity": "14.031 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, \tAL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, \tVA, 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.", "openfda": { "k_number": [ "K132133", "K143701", "K222568", "K070242", "K030524", "K251103", "K033650", "K230453", "K071554", "K071660", "K173063", "K252945", "K092064", "K123813", "K140318", "K081625", "K092596", "K081808", "K153094", "K223766", "K251211", "K200812", "K253399", "K133853", "K193183", "K173820", "K031346", "K172258", "K103260", "K081626", "K173284", "K153617", "K240050", "K233270", "K213593", "K121273", "K111043", "K051679", "K120697", "K200410", "K203726", "K170263", "K260816", "K201775", "K042593", "K163478", "K123621", "K223077", "K251231", "K261849", "K041727", "K113008", "K141618", "K080891", "K041134", "K152829", "K071234", "K173618", "K073473", "K242893", "K170992", "K261696", "K191175", "K161125", "K160514", "K233948", "K112050", "K212959", "K250955", "K150442", "K241540", "K122878", "K101138", "K160583", "K091352", "K200195", "K250913", "K051337", "K050995", "K103255" ], "registration_number": [ "3033527283", "3016678045", "9710602", "2032112", "9612283", "3011610434", "3009077524", "1721686", "3015551113", "3002619337", "3038966633", "3011416394", "2024311", "3031397684", "9680794", "3005403518", "3008452825", "3032109181", "2030404", "3019807891", "3008516548", "3010273872", "3012179728", "2124215", "1225687", "1061124", "2518586", "9617277", "9610482", "3005467144", "3008496839", "3009537152", "8010026", "3014272734", "3014745562", "3007695959", "3009350690", "1000601180", "3033508292", "2032350", "3013403214", "3015276088", "3003594449", "3035950510", "3013944123", "8043817", "1058584", "3009490946", "3003493679", "3008497357", "3008363989", "3007738736", "3013734919", "3005877899", "2939520", "3032807464", "3033527241", "3013162291", "2090040", "3013300026", "3017461134", "3019216", "9673241", "3003898360", "2182269", "2011171", "3010220595", "3012127758", "9681834", "3015542130", "2531814", "3009196578", "3010041511", "2134265", "9680579", "1928237", "3005334138", "3016171942", "3010952312", "3006985147", "3012198618", "3009888344", "3013844297", "3010432890", "3011137372", "3012833053", "3011763071", "3038718997", "3000126629", "3005012805", "3017060084", "3023245", "2134243", "2030624", "2029275", "3016076141", "3015859709", "3017894900", "3010398867", "2532090" ], "fei_number": [ "3033527283", "3016678045", "3002808457", "2828", "3011610434", "3002626007", "1000306431", "3009077524", "1721686", "1000512168", "3015551113", "3002619337", "3003094575", "3038966633", "3011416394", "2024311", "3031397684", "3005403518", "3002095335", "3008452825", "3032109181", "3019807891", "3008516548", "3010273872", "3012179728", "2124215", "3005747797", "2518586", "3002808327", "3005467144", "3008496839", "3009537152", "3003248396", "3014272734", "1000519796", "3014745562", "3007695959", "3009350690", "3001451463", "1000601180", "3033508292", "3003408255", "3013403214", "3015276088", "3003594449", "3035950510", "3013944123", "3003309342", "3000206435", "3009490946", "3003493679", "3008497357", "3008363989", "3003076831", "3007738736", "3013734919", "1000219637", "3003190524", "3005877899", "3003513129", "2939520", "3032807464", "3033527241", "3013162291", "3003737899", "3013300026", "3017461134", "3019216", "3003898360", "3002808529", "3002615969", "2182269", "2011171", "3010220595", "3012127758", "3015542130", "1000203464", "3009196578", "3010041511", "3001726808", "1928237", "3005334138", "3016171942", "3010952312", "3006985147", "3012198618", "3009888344", "3013844297", "3010432890", "3012833053", "3011763071", "3038718997", "3000126629", "3005012805", "3017060084", "3023245", "3016076141", "3015859709", "3017894900", "3010398867" ], "device_name": "Catheter, Ultrasound, Intravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ] }