{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "184740", "product_res_number": "Z-0757-2021", "event_date_initiated": "2020-11-16", "event_date_created": "2020-12-30", "recall_status": "Open, Classified", "res_event_number": "86880", "product_code": "FAD", "k_numbers": [ "K974541" ], "product_description": "Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570", "code_info": "GTIN 08714729058410:  Lots  25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349.   GTIN 08714729067986:  Lots  25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104.   GTIN 08714729068020:  Lots  25578740, 25583824.", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "300 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1291", "additional_info_contact": "Nicole Pshon\n763-494-1133", "reason_for_recall": "Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.", "root_cause_description": "Process design", "action": "On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions:\n\n- Verify whether you have any product from the affected lots/batches within your inventory\n- Immediately cease use or distribution of any remaining unused product from the affected lots/batches\n - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. \n- Distributors should forward the notification to their customers\n\nYour local Sales Representative can answer any questions that you may have regarding this notification.", "product_quantity": "458 units", "distribution_pattern": "Distribution US nationwide and Japan.", "openfda": { "k_number": [ "K961446", "K022447", "K161236", "K060673", "K881744", "K865085", "K983498", "K251890", "K834401", "K040760", "K832915", "K905505", "K850176", "K180029", "K162104", "K013784", "K904231", "K871667", "K830884", "K163068", "K213444", "K033210", "K180469", "K021140", "K914280", "K151051", "K190603", "K862539", "K172017", "K031292", "K030503", "K861478", "K823487", "K191446", "K163399", "K960148", "K181971", "K873557", "K063742", "K930731", "K880660", "K180216", "K201436", "K213186", "K162109", "K180557", "K232920", "K190312", "K180057", "K800109", "K920695", "K961371", "K171603", "K981491", "K871291", "K851870", "K923394", "K161277", "K946296", "K082805", "K872353", "K860055", "K974541", "K852389", "K860267", "K180053", "K875038", "K930882", "K831857", "K243830", "K850175", "K910691", "K894357", "K011264", "K212868", "K840059", "K925282", "K905289", "K981591", "K820870", "K211934", "K190659", "K243039", "K172289", "K213185", "K883561", "K864225", "K043193", "K933941", "K992391", "K903345", "K833782", "K912060", "K072293", "K781641", "K010002", "K200260", "K141344", "K854862", "K882157", "K913928", "K863492", "K864669", "K930733", "K021602", "K973504", "K170422", "K170362", "K191609", "K251469", "K160891", "K013921", "K941952", "K982974", "K991219", "K981489", "K831446", "K173734", "K854908", "K952513", "K170010", "K250824" ], "device_name": "Stent, Ureteral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4620", "device_class": "2", "registration_number": [ "9681477", "9617744", "3015225571", "3005987240", "2030624", "3009526575", "1828132", "3013023255", "9681442", "1037955", "3016096097", "3007156625", "3010131137", "3003790304", "3006950086", "1820334", "2246552", "3012536737", "3013460719", "3010155661", "3011642792", "1225687", "1048735", "3033589330", "3010273872", "1646831", "3030087693", "3024807849", "3009051888", "3005232773", "3008797804", "9681260", "3001845648", "2183744", "2126666", "2124215", "3002807314", "1647149", "1000393132", "9610711", "1825146", "3016678045", "3017210488", "3012050423", "3007695959", "9611590", "3004859241", "1220477", "3014246639", "3015309643", "3003915875", "1313046", "3005099803", "3006082230", "1000121056", "2527072", "3012649202", "3003814961", "1018233", "3005941719", "3005580113", "3004365956", "3011050570", "2027111", "3009763019", "1424778", "3033848208", "1123137", "2125050", "3021632375", "1721504" ], "fei_number": [ "3005987240", "3015225571", "3000206435", "3009526575", "1828132", "3008133910", "3013023255", "1037955", "3016096097", "3002806368", "3010131137", "3003790304", "3006950086", "1820334", "2246552", "3012536737", "3013460719", "3010155661", "3011642792", "3006279007", "1048735", "3033589330", "3010273872", "1000237915", "3030087693", "3024807849", "3009051888", "3005232773", "3008797804", "3003473227", "3001845648", "2183744", "2126666", "1000123180", "2124215", "3002807314", "1000160215", "1000393132", "1825146", "3016678045", "3002807917", "3017210488", "3012050423", "3007695959", "3002807439", "3004859241", "1220477", "3014246639", "3015309643", "3003915875", "1313046", "3005099803", "3002806565", "1000121056", "3006082230", "2527072", "3012649202", "3003814961", "1018233", "3002807111", "3005580113", "3004365956", "3011050570", "2027111", "3009763019", "3033848208", "2125050", "3021632375", "3001451463", "1721504", "1000306139" ] } } ] }