{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140078", "product_res_number": "Z-0003-2016", "event_date_initiated": "2015-09-10", "event_date_posted": "2015-10-01", "recall_status": "Terminated", "event_date_terminated": "2016-05-13", "res_event_number": "72167", "product_code": "OBJ", "k_numbers": [ "K140318" ], "product_description": "SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.", "code_info": "Catalog #: 10439236, 10439072, 10439011, 10438577", "firm_fei_number": "3003113629", "recalling_firm": "Biosense Webster, Inc.", "address_1": "15715 Arrow Hwy", "city": "Irwindale", "state": "CA", "postal_code": "91706-2006", "additional_info_contact": "Vadim Kastin\n909-839-8500", "reason_for_recall": "Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.", "root_cause_description": "Device Design", "action": "A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site.\n\nThe firm's notification letter stated that they want to emphasize the following statement \"The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ultrasound to monitor the patien during EP procedure. The ultrasound image will not reappear until the CARTO 3 System is restored.\"\n\nThe firm will be updating the product labeling to further reinforce the precautionary statement.\n\nThe firm requests that customers take the following actions:\n1. Read the Field Safety Notification carefully.\n2. Pass on this notification to anyone in the facility that needs to be informed of this issue, including appropriate clinical personnel involved in the use of SOUNDSTAR eco Catheters.\n3. Review, complete, sign and return the attached Acknowledgement Form in accordance with the instructions on the form. \n4. Maintain a copy of this letter with the product.\n5. Maintain awareness of the Field Safety Notification\n\nFor any questions the firm states to contact the BWI sales representative.", "product_quantity": "1035 (U.S.)", "distribution_pattern": "Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.", "openfda": { "k_number": [ "K251231", "K160583", "K141618", "K213593", "K080891", "K200812", "K193183", "K081625", "K233270", "K200195", "K251211", "K153617", "K160514", "K222568", "K092596", "K173820", "K103255", "K252945", "K250955", "K241540", "K123813", "K152829", "K170992", "K170263", "K253399", "K132133", "K212959", "K230453", "K261849", "K050995", "K250913", "K201775", "K163478", "K041727", "K200410", "K240050", "K091352", "K123621", "K242893", "K033650", "K223766", "K071660", "K111043", "K122878", "K172258", "K223077", "K113008", "K191175", "K120697", "K071554", "K041134", "K143701", "K173618", "K133853", "K051679", "K203726", "K073473", "K103260", "K173284", "K233948", "K031346", "K081626", "K071234", "K101138", "K161125", "K140318", "K081808", "K051337", "K153094", "K173063", "K260816", "K030524", "K112050", "K150442", "K251103", "K092064", "K121273", "K042593", "K070242" ], "registration_number": [ "3013403214", "3010432890", "3033527283", "2134243", "1058584", "2029275", "3012179728", "9617277", "3008497357", "2518586", "2124215", "3011610434", "3019216", "8010026", "3012833053", "3016678045", "3003594449", "3009077524", "3033527241", "9612283", "3010952312", "2011171", "2024311", "1225687", "2030404", "1721686", "2032112", "3003898360", "9680579", "9610482", "8043817", "3014272734", "3031397684", "3007738736", "3009350690", "3011416394", "3013734919", "3003493679", "2090040", "3015276088", "3010041511", "3005467144", "3012127758", "2134265", "3032109181", "3014745562", "9673241", "3010398867", "3012198618", "3006985147", "3000126629", "9710602", "3005334138", "1000601180", "3008452825", "3007695959", "3017060084", "9681834", "3023245", "3008496839", "3009196578", "2032350", "2531814", "2182269", "3008363989", "3038966633", "3015551113", "3016171942", "1061124", "3008516548", "3017894900", "3017461134", "3005877899", "3015859709", "3002619337", "3019807891", "3011763071", "3009888344", "3035950510", "3033508292", "3013844297", "3032807464", "3005403518", "3013162291", "1928237", "3009537152", "3010273872", "3016076141", "2030624", "9680794", "3013944123", "3011137372", "3005012805", "2939520", "3013300026", "3009490946", "3038718997" ], "fei_number": [ "3013403214", "3010432890", "3033527283", "1000219637", "3005747797", "3002626007", "3012179728", "3001451463", "1000203464", "3008497357", "2518586", "2124215", "2828", "3011610434", "3019216", "3012833053", "3002808327", "3003513129", "3016678045", "3003594449", "3003248396", "3000206435", "1000519796", "3009077524", "3033527241", "3003190524", "3003309342", "3010952312", "2011171", "3003076831", "2024311", "1721686", "3003898360", "1000306431", "3014272734", "3031397684", "3001726808", "3007738736", "3009350690", "3011416394", "3013734919", "3003493679", "3015276088", "3010041511", "3005467144", "3012127758", "3032109181", "3014745562", "3010398867", "3012198618", "3006985147", "3000126629", "3005334138", "1000601180", "3002095335", "3008452825", "3007695959", "3017060084", "3023245", "3008496839", "3009196578", "3003737899", "1000512168", "2182269", "3008363989", "3038966633", "3015551113", "3016171942", "3008516548", "3017894900", "3017461134", "3005877899", "3015859709", "3002619337", "3002808529", "3019807891", "3011763071", "3009888344", "3035950510", "3033508292", "3013844297", "3032807464", "3003094575", "3005403518", "3013162291", "1928237", "3009537152", "3002808457", "3010273872", "3016076141", "3013944123", "3005012805", "2939520", "3002615969", "3013300026", "3009490946", "3038718997" ], "device_name": "Catheter, Ultrasound, Intravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ] }