{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183804", "product_res_number": "Z-0286-2021", "event_date_initiated": "2020-09-16", "event_date_created": "2020-10-23", "recall_status": "Open, Classified", "res_event_number": "86476", "product_code": "FGE", "k_numbers": [ "K130484" ], "product_description": "Hurricane RX Biliary Balloon Dilatation Catheter\nCatalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960\n\nThe device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.", "code_info": "Hurricane RX Dilation Balloon 4 mm 2 cm UPN/REF # M00545890 GTIN # 08714729283805 Lot/Batch # 25509445, 25536219, 25612668, 25649812, 25704208 EXP Date Range 04/13/2022 - 06/13/2022  Hurricane RX Dilation Balloon 4 mm 4 cm UPN/REF # M00545900 GTIN # 08714729283812 Lot/Batch #  25326198, 25344165, 25344168, 25366542, 25366543, 25379240, 25379241, 25392546, 25447687, 25447688, 25447689, 25447690, 25447691, 25447692, 25453103, 25453105, 25453108, 25466435, 25468596, 25468597, 25471588, 25479171, 25479176, 25479177, 25479178, 25479521, 25481983, 25481984, 25481985, 25481986, 25497466, 25497467, 25497468, 25506678, 25509440, 25509446, 25509447, 25509450, 25518274, 25518305, 25518314, 25533944, 25536416, 25536680, 25536860, 25543967, 25543969, 25571363, 25575934, 25575935, 25576717, 25576718, 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771765 EXP Date Range 02/07/2022 - 06/27/2022  Hurricane RX Dilation Balloon 6 mm 2 cm UPN/REF # M00545910 GTIN #08714729283829 Lot/Batch # 25456946, 25497472, 25571369, 25623385, 25678822, 25739151 EXP Date Range 03/22/2022 - 06/20/2022  Hurricane RX Dilation Balloon 6 mm 4 cm UPN/REF # M00545920 GTIN # 08714729283836 Lot/Batch # 25305803, 25326193, 25326194, 25326195, 25326199, 25334817, 25334818, 25366544, 25366545, 25366546, 25366547, 25392549, 25392551, 25392553, 25392554, 25392555, 25397943, 25397944, 25447697, 25447698, 25453106, 25453109, 25461680, 25466436, 25468598, 25472425, 25475235, 25475236, 25479172, 25479173, 25479179, 25481987, 25481988, 25481989, 25481990, 25481991, 25497469, 25497470, 25497473, 25497474, 25497475, 25509412, 25509413, 25509414, 25509451, 25509452, 25509453, 25518276, 25518306, 25518307, 25518315, 25518316, 25536681, 25536739, 25536740, 25543970, 25543971, 25543972, 25543973, 25571370, 25571373, 25576770, 25576771, 25576772, 25576773, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773 EXP Date Range 02/02/2022 - 06/27/2022  Hurricane RX Dilation Balloon 8 mm 2 cm UPN/REF # M00545930 GTIN # 08714729283843 Lot/Batch # 25509441, 25536741, 25644951, 25649190, 25650286, 25651334, 25654287 EXP Date Range 04/13/2022 - 05/31/2022  Hurricane RX Dilation Balloon 8 mm 4 cm UPN/REF # M00545940 GTIN # 08714729283850 Lot/Batch # 25317077, 25326196, 25326220, 25326221, 25326222, 25334819, 25344169, 25366548, 25366549, 25392556, 25392557, 25397079, 25447693, 25447694, 25453104, 25453107, 25453110, 25466437, 25468599, 25471589, 25471590, 25475234, 25479174, 25479175, 25479520, 25479580, 25481992, 25497051, 25497052, 25502738, 25509415, 25509416, 25509417, 25509418, 25509419, 25509442, 25509448, 25509454, 25509546, 25518277, 25518278, 25518317, 25518318, 25536682, 25536742, 25536743, 25543975, 25543976, 25543977, 25543978, 25543979, 25544020, 25571371, 25571374, 25596599, 25602458, 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801 EXP Date Range 02/04/2022 - 06/30/2022  Hurricane Rx Dilation Balloon 10 mm 2 cm UPN/REF # M00545950 GTIN # 08714729283867 Lot/Batch # 25471587, 25571372, 25588303, 25673064 EXP Date Range 03/28/2022 - 06/06/2022  Hurricane RX Dilation Balloon 10 mm 4 cm UPN/REF # M00545960 GTIN # 08714729283874 Lot/Batch # 25334980, 25344170, 25344171, 25366550, 25378999, 25397945, 25397950, 25447685, 25447695, 25447696, 25461681, 25464817, 25466438, 25471591, 25471592, 25484487, 25493901, 25497471, 25497476, 25509443, 25509444, 25509449, 25518279, 25518308, 25518309, 25536683, 25544022, 25544023, 25544024, 25544025, 25571375, 25602323, 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170 EXP Date 02/08/2022 - 06/20/2022", "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": "RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.", "root_cause_description": "Vendor change control", "action": "All consignees were sent a copy of the customer notification letter via Federal Express Priority Overnight mail on 09/16/2020. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to BSC. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. \n\nFollow-up communications will be made to the accounts that do not respond to this inquiry.\n\nThe returned products will be quarantined until an appropriate course of action has been determined. BSC will notify FDA of this decision prior to its implementation.", "product_quantity": "15,062 devices distributed in US. 12,930 distributed OUS", "distribution_pattern": "Worldwide distribution - US Nationwide and International distribution.", "openfda": { "k_number": [ "K012087", "K954713", "K021345", "K914277", "K042518", "K973171", "K935094", "K003186", "K982005", "K993892", "K961216", "K901432", "K232596", "K251229", "K183396", "K030638", "K101095", "K053404", "K032025", "K143303", "K072301", "K023308", "K963691", "K021994", "K933200", "K061231", "K851962", "K851960", "K001258", "K203162", "K060487", "K014007", "K896503", "K020052", "K940965", "K924451", "K991533", "K993303", "K040667", "K961262", "K980653", "K040151", "K024048", "K022026", "K863957", "K033834", "K912971", "K896504", "K000793", "K913073", "K011184", "K861291", "K050725", "K963767", "K923096", "K031197", "K152607", "K002130", "K972583", "K163169", "K233079", "K020682", "K013737", "K993904", "K051785", "K162404", 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"K010107", "K211021", "K973008", "K143609", "K993091", "K992816", "K834413", "K863571", "K873954", "K921654", "K021672", "K090133", "K963254", "K992755", "K905707", "K102519", "K896506", "K924387", "K011806", "K913986", "K912122", "K901431", "K222663", "K241888", "K253393", "K863437", "K253832", "K974815", "K990854", "K860990", "K020809", "K223354", "K050502", "K002650", "K051124", "K171623", "K924107", "K991674", "K040800", "K896391", "K915813", "K003997", "K853543", "K060057", "K834351", "K992318", "K040027", "K033212", "K023870", "K041032", "K081184", "K040413", "K030107", "K983154", "K120452", "K251658", "K032436", "K954043", "K021824", "K994156", "K111766", "K112522", "K033537", "K251019", "K003753", "K965147", "K833937", "K011080", "K896069", "K061235", "K963397", "K033348", "K112994", "K011881", "K011039", "K990631", "K002101", "K011506", "K896423", "K043243", "K962925", "K122546", "K223626", "K003793", "K014205", "K093003", "K040653", "K892384", "K003365", "K052114", "K955110", "K171548", "K230127", "K012590", "K081996", "K031777", "K904669", "K000864", "K213946", "K014136", "K151671", "K050698", "K043481", "K200103", "K880343", "K032360", "K032206", "K080037", "K180868", "K130981", "K914699", "K111315", "K141335", "K232245", "K011817", "K910931", "K000308", "K063481", "K221071", "K030645", "K000550", "K063733", "K012216", "K001222", "K894871", "K031360", "K873606", "K003040", "K953332", "K910493", "K010549", "K944912", "K202477", "K931025", "K024303", "K821817", "K121430", "K991028", "K823428", "K000744", "K050534", "K241801", "K011909", "K920361", "K093893", "K141597", "K003450", "K172057", "K031186", "K913841", "K223592", "K970052", "K945498", "K052132", "K912288", "K130484", "K072720", "K162226", "K040930", "K112701", "K110122", "K851647", "K082093", "K060877", "K010684", "K901582", "K911292", "K821819", "K163018", "K081733", "K010411", "K003929", "K980372", "K964119", "K851242", "K083374", "K041606", "K033134", "K101314", "K991793", "K910219", "K900923", "K150487", "K103353", "K994068", "K964688", "K991032", "K833920", "K032929", "K172520", "K900904", "K010445", "K905714", "K180086", "K982508", "K020788", "K830483", "K012347", "K180418", "K173035", "K980290", "K240464", "K010714", "K963782", "K071646", "K001843", "K140760", "K050103", "K953827", "K140630", "K012822", "K103478", "K050501", "K002235", "K941973", "K925406", "K253132", "K062264", "K040505", "K112543", "K990592", "K862059", "K002133", "K896518", "K170740", "K023121", "K152853", "K023248", "K872509", "K223469", "K852293", "K910671", "K972825", "K012066", "K991929", "K042969", "K934377", "K012090", "K972582", "K993145", "K041962", "K914495", "K023217", "K921191", "K010601", "K111627", "K901433", "K940370", "K072708", "K070610", "K063532", "K023666", "K001338", "K910006", "K914881", "K002143", "K250409", "K050777", "K993392", "K033497", "K902107", "K033394", "K983075", "K973114", "K855142", "K030633", "K992569", "K905229", "K052539", "K955413", "K901427", "K851956", "K102082", "K930623", "K053454", "K111149", "K210419", "K882610", "K914882", "K042204", "K171223", "K251291", "K990130", "K910768", "K900205", "K923993", "K920236", "K001224", "K033862", "K050627", "K032530", "K133110", "K202973", "K993588", "K853666", "K243412", "K012752", "K014215", "K141408", "K051379", "K993646", "K172044", "K060817", "K170743", "K980823", "K010242", "K073672", "K033393", "K020528", "K152069", "K962899", "K122072", "K924608", "K131201", "K851954", "K903420", "K171809", "K042985", "K101786" ], "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "3003775027", "", "1644312", "9681477", "3007146453", "3011163668", "3005580113", "3001845648", "9616099", "1000393132", "1319639", "3013526170", "2528981", "3009763019", "3004207966", "1721504", "2020394", "9681260", "8010047", "3003898360", "1531050", "3009051888", "3007695959", "3003902943", "3011347300", "3011642792", "2126666", "3013247477", "3006082230", "3005941719", "1317547", "3010419931", "1721676", "3033589330", "1000121056", "3012480535", "2032098", "1319211", "3010220595", "3004111573", "1643817", "3004091615", "3006131984", "1222168", "3040096051", "9710641", "3031276312", "1016427", "3004837686", "3040505963", "2939561", "3016463905", "9681442", "1220592", "3013557562", "1220477", "1058584", "9710284", "2124215", "3010155661", "2246552", "1219930", "1123137", "3003910212", "1820334", "3015225571", "3009121749", "3030446844", "3011689956", "2029386", "9680794", "2030624", "2024168", "1450395", "3002807090", "2134265", "2183744", "2183870", "3004859241", "1928237", "3011137372", "1061124", "3009906660", "3008040402", "3030447506", "2011171", "3012536737", "3009526575", "1417485", "3014769442", "3011146996", "2648045", "3011458193", "3009018440", "3006891655", "9616684", "1528319", "3013152301", "3021009035", "1625425", "3027260597", "3014246639", "1225687", "1320894", "3010173425", "3006260740", "3014579161", "3014222368", "1724474", "3002807314", "1828132", "3005987240", "3035451914", "3014328942", "2027111", "3006950086", "3013162291", "3005099803", "3013440400", "3030733800", "3005089785", "3014279513", "3010273872", "3008146331", "1000523114", "3021632375", "1037905", "3013337852", "3004129994", "1018233", "3016678045", "3002504068", "3011050570", "2024024", "3015309643", "3032916632", "9614641", "1223925", "1313046", "9680809", "3000247987", "3003790304", "3010532612", "3013460719", "3008492676" ], "fei_number": [ "3003775027", "", "1000122656", "3007146453", "3011163668", "3005580113", "3001845648", "1000393132", "3013526170", "2528981", "3009763019", "3002095335", "3004207966", "1721504", "2020394", "1000117748", "3003898360", "3009051888", "3003094851", "3002755653", "3007695959", "3003902943", "3011347300", "1000138054", "3011642792", "2126666", "3002807439", "3002807111", "3013247477", "1000306647", "3006082230", "3000206435", "1317547", "3010419931", "1721676", "3033589330", "1000121056", "1000219637", "3012480535", "3003565456", "1319211", "3010220595", "3004111573", "1643817", "3004091615", "3006131984", "1222168", "3040096051", "3031276312", "1016427", "3004837686", "3006003617", "3005747797", "3040505963", "1000512168", "3016463905", "1220592", "3013557562", "3003528016", "1220477", "2124215", "3010155661", "2246552", "1219930", "3004635528", "3002995060", "3003910212", "1820334", "3015225571", "3009121749", "1000305720", "3030446844", "3011689956", "3001451571", "2024168", "1450395", "2183744", "3003084171", "3002913962", "3003995201", "3004859241", "1928237", "2183870", "3009906660", "3008040402", "3030447506", "2011171", "3012536737", "3002806368", "3009526575", "1417485", "3014769442", "3011146996", "2648045", "3011458193", "3009018440", "3006891655", "3002806565", "3003737899", "1000123180", "3013152301", "3021009035", "1625425", "3002807036", "3027260597", "3014246639", "3002807795", "3006260740", "3014579161", "3014222368", "3002807314", "3001451463", "1828132", "3005987240", "3035451914", "3014328942", "2027111", "3006950086", "3013162291", "3005099803", "3013440400", "3030733800", "3005089785", "3014279513", "3010273872", "3008146331", "1000523114", "3021632375", "1037905", "3013337852", "3004129994", "1018233", "3016678045", "3002504068", "3011050570", "2024024", "3015309643", "3032916632", "1313046", "3000247987", "3003058448", "3003790304", "3010532612", "3013460719", "3008492676" ] } } ] }