{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217716", "product_res_number": "Z-1042-2026", "event_date_initiated": "2025-12-03", "event_date_posted": "2026-01-09", "recall_status": "Open, Classified", "res_event_number": "98149", "product_code": "LIT", "k_numbers": [ "K111295" ], "product_description": "Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, \n1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; \n2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; \nCatheter, Angioplasty, Peripheral, Transluminal", "code_info": "1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28; \n2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "Clara Johnson\n763-494-1133", "reason_for_recall": "Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.", "root_cause_description": "Process change control", "action": "Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 12/3/2025 by letter delivered via a courier service. The notice explained the issue, clinical impact to the patient, and requested the following actions: \n\"Instructions:\n1. Further distribution or use of any remaining devices (Attachment 1) affected by this\nremoval should cease immediately.\nDo NOT use affected devices and remove those devices from your facility s inventory. Segregate\nthe units in a secure place until they can be returned to Boston Scientific.\n2. Immediately post this information in a visible location near the affected devices to ensure it is\nreadily accessible to all handlers and users of the device.\n3. Forward this notice to any healthcare professional from your organization and to any facilities\nwhere affected devices have been transferred, including hospitals or sites within your network.\nIf you are a distributor, this notice must be forwarded to your customers to ensure notification of\nthis device removal is carried out to the end-user level.\n4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed\ninstructions on page four.\n5. Return affected devices.\" \nFor questions regarding this communication, please contact your local Boston Scientific\nrepresentative.", "product_quantity": "21 units", "distribution_pattern": "US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.", "openfda": { "k_number": [ "K121265", "K062843", "K853746", "K991811", "K951248", "K150452", "K093139", "K172494", "K133861", "K143193", "K962945", "K112797", "K142379", "K132020", "K180007", "K141150", "K911215", "K143041", "K120164", "K162350", "K952884", "K850075", "K121402", "K961980", "K911089", "K221832", "K945465", "K933975", "K122070", "K092286", "K093286", "K221245", "K851848", "K954313", "K200700", "K241040", "K173621", "K051916", "K120805", "K953569", "K051519", "K093970", "K831403", "K101062", "K911196", "K862550", "K831659", "K143652", "K173894", "K910996", "K913112", "K050645", "K260304", "K921577", "K885247", "K880612", "K934378", "K172033", "K952063", "K102645", "K130161", "K152873", "K071042", "K241740", "K132777", "K872542", "K972357", "K972512", "K090364", "K842556", "K023504", "K912984", "K851080", "K201794", "K241711", "K925485", "K970620", "K973563", "K944815", "K924358", "K102705", "K151153", "K092361", "K163231", "K190037", "K111899", "K883346", "K972744", "K143036", "K981906", "K142654", "K844972", "K220410", "K913297", "K913689", "K092455", "K201246", "K903606", "K897106", "K971579", "K921706", "K080982", "K243704", "K141118", "K970379", "K150946", "K102035", "K103354", "K113468", "K926271", "K192399", "K000798", "K072765", "K101361", "K875175", "K130397", "K141112", "K830608", "K170193", "K933236", "K924276", "K983055", "K210626", "K910995", "K944989", "K122379", "K181128", "K201333", "K221057", "K950119", "K110319", "K942150", "K192907", "K201170", "K223177", "K072798", "K911639", "K222065", "K130911", "K152080", "K963688", "K895179", "K251915", "K142261", "K190753", "K003114", "K252512", "K130786", "K833248", "K813331", "K152665", "K900677", "K133843", "K914976", "K893411", "K100490", "K221339", "K881197", "K143561", "K021996", "K882925", "K880158", "K170635", "K941706", "K030062", "K212215", "K171290", "K133043", "K897124", "K953608", "K101047", "K113769", "K241025", "K904410", "K181323", "K880298", "K991977", "K102482", "K923638", "K971448", "K020854", "K073472", "K971577", "K992825", "K152230", "K161427", "K904984", "K041293", "K103464", "K881088", "K911203", "K132430", "K960517", "K250706", "K902367", "K913391", "K151744", "K131199", "K111295", "K925945", "K862467", "K935501", "K001087", "K132810", "K923611", "K130414", "K230263", "K890325", "K882052", "K880194", "K160941", "K120660", "K060960", "K131329", "K093965", "K123358", "K992320", "K003276", "K191275", "K952064", "K912317", "K142459", "K843501", "K911870", "K905773", "K120722", "K173515", "K964881", "K902454", "K160004", "K151317", "K122984", "K955886", "K162316", "K991540", "K934793", "K071309", "K123544", "K942635", "K894944", "K081417", "K843383", "K901601", "K981407", "K142300", "K822245", "K832474", "K060959", "K230191", "K945943", "K000570", "K120677", "K896520", "K093636", "K214038", "K142954", "K100921", "K201377", "K970299", "K921943", "K884481", "K953602", "K121856", "K113681", "K905250", "K121175", "K160013", "K980390", "K001134", "K160256", "K931009", "K080925", "K151141", "K121385", "K112513", "K181529", "K963000", "K911130", "K915168", "K901018", "K944016", "K915895", "K924047", "K120971", "K945693", "K121442", "K965183", "K934433", "K073318", "K103751", "K915349", "K933483", "K130293", "K841961", "K152240", "K875064", "K851854", "K803057", "K942094", "K093720", "K953298", "K871011", "K894250", "K934411", "K970725", "K071189", "K833616", "K890800", "K910155", "K171251", "K163479", "K052757", "K983650", "K120738", "K192318", "K943298", "K152934", "K901767", "K202231", "K871796", "K030742", "K040954", "K870215", "K844913", "K972800", "K850760", "K103322", "K152887", "K000101", "K903582", "K930745", "K894899", "K923826", "K151678", "K003052", "K902317", "K993305", "K063563", "K900094", "K942400", "K915347", "K140351", "K933183", "K924320", "K931384", "K903417", "K953647", "K143093", "K003159", "K213631", "K080264", "K914500", "K921856", "K231402", "K896403", "K834429", "K150303", "K830733", "K942154", "K241683", "K882826", "K072824", "K843880", "K812168", "K214009", "K242419", "K141521", "K221414", "K922610", "K834220", "K112697", "K051042", "K874706", "K934191", "K052038", "K905698", "K923947", "K993913", "K940063", "K971010", "K920547", "K902091", "K940868", "K113300", "K003972", "K960501", "K971516", "K072947", "K970466", "K983830", "K932537", "K211044", "K973013", "K854319", "K910965", "K921254", "K946052", "K884327", "K202800", "K910822", "K942293", "K993639", "K890405" ], "pma_number": [ "P950020" ], "registration_number": [ "9617601", "3009018440", "1721676", "2024168", "3019677404", "9681477", "2020394", "3004091615", "2134265", "1647149", "3011088743", "3015002281", "9617592", "3005994106", "3006550224", "1282497", "2528981", "1055236", "1220452", "3008700817", "3012448339", "3015910259", "3002806603", "3002807314", "1646831", "1043214", "3000247873", "1016427", "3010432890", "3010391265", "3030574705", "3013944123", "3048102902", "3015453963", "9616666", "3016591327", "3008361782", "1422634", "9681260", "1643817", "3027395815", "2183870", "3018805824", "3022627847", "2030598", "3016678045", "1000393132", "3003775186", "1318694", "2134626", "3014390222", "3009564766", "3005580113", "3005718570", "1028232", "3004730544", "1319639", "3004415014", "1820334", "3011471056", "9618000", "2124215", "3012050423", "8043892", "2939561", "3007738736", "2024024", "1018233", "1313046", "1054241", "3014656749", "1225687", "3002807090", "3014222368", "9614654", "1000563940", "3010273872", "1219930", "3027343398", "3006082230", "3010220595", "3011142981", "3014687026", "3010291427", "3021140368", "3008261722", "3009965866", "1000121056", "3013391155", "3016927279", "2011171", "3002807315", "1721686", "2183744" ], "fei_number": [ "1000518731", "3009018440", "1721676", "2024168", "3019677404", "1000138054", "2020394", "3004091615", "3011088743", "3015002281", "3002807439", "3005994106", "3002806565", "3006550224", "1282497", "2528981", "1220452", "3008700817", "3012448339", "3015910259", "3008906816", "3002806603", "3002807314", "1043214", "3000247873", "1016427", "3010432890", "1000160215", "3010391265", "3001451463", "3030574705", "3013944123", "3048102902", "3015453963", "3016591327", "3008361782", "1643817", "3027395815", "2183870", "3018805824", "3022627847", "3016678045", "1000393132", "3003775186", "1318694", "3002808050", "3002534070", "3002808904", "3014390222", "3009564766", "3005580113", "3005718570", "3003245778", "3002095335", "1028232", "3004730544", "3004415014", "1820334", "1000112968", "3011471056", "3003007911", "2124215", "3012050423", "3004635528", "3007738736", "2024024", "1018233", "1313046", "3014656749", "3006003617", "3014222368", "1000563940", "3010273872", "1000112877", "1219930", "3027343398", "3006082230", "1000514656", "3010220595", "3011142981", "3014687026", "3010291427", "3021140368", "3008261722", "3009965866", "1000121056", "3013391155", "3016927279", "3002468371", "2011171", "1000306139", "3002807315", "1721686", "2183744" ], "device_name": "Catheter, Angioplasty, Peripheral, Transluminal", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }