{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176381", "product_res_number": "Z-0122-2020", "event_date_initiated": "2019-09-03", "event_date_created": "2019-10-11", "recall_status": "Open, Classified", "res_event_number": "83797", "product_code": "LOX", "k_numbers": [ "K143480" ], "product_description": "Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, 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701 EUP22510X\t00643169559943\t217799181 EUP22512X\t00643169559950\t217225189 EUP22512X\t00643169559950\t217379136 EUP22512X\t00643169979673\t217480196 EUP22512X\t00643169979673\t217535801 EUP22512X\t00643169559950\t217646817 EUP22512X\t00643169979673\t217704797 EUP22512X\t00643169559950\t217786009 EUP22512X\t00643169559950\t217860169 EUP22512X\t00643169979673\t217884481 EUP22515X\t00643169559967\t217282748 EUP22515X\t00643169559967\t217290757 EUP22515X\t00643169979246\t217396793 EUP22515X\t00643169559967\t217479185 EUP22515X\t00643169979246\t217584301 EUP22515X\t00643169618466\t217601075 EUP22515X\t00643169559967\t217675576 EUP22515X\t00643169618466\t217704796 EUP22515X\t00643169559967\t217713357 EUP22515X\t00643169979246\t217742355 EUP22515X\t00643169979246\t217791228 EUP22515X\t00643169979246\t217884480 EUP22520X\t00643169559974\t217239782 EUP22520X\t00643169618824\t217370778 EUP22520X\t00643169559974\t217418946 EUP22520X\t00643169979604\t217601084 EUP22520X\t00643169979604\t217713406 EUP22520X\t00643169559974\t217721627 EUP22525X\t00643169559981\t217262441 EUP22525X\t00643169559981\t217465234 EUP22525X\t00643169979710\t217535799 EUP22525X\t00643169979710\t217799308 EUP22525X\t00643169979710\t217876346 EUP22525X\t00643169559981\t217881225 EUP2506X\t00643169559998\t217239781 EUP2506X\t00643169979550\t217370777 EUP2506X\t00643169559998\t217505523 EUP2506X\t00643169559998\t217859380 EUP2506X\t00643169559998\t217932670 EUP2510X\t00643169979512\t217262906 EUP2510X\t00643169618732\t217262910 EUP2510X\t00643169979512\t217282160 EUP2510X\t00643169979512\t217291001 EUP2510X\t00643169560000\t217347818 EUP2510X\t00643169979512\t217444060 EUP2510X\t00643169979512\t217451568 EUP2510X\t00643169560000\t217505524 EUP2510X\t00643169560000\t217535673 EUP2510X\t00643169979512\t217602586 EUP2510X\t00643169618732\t217616437 EUP2510X\t00643169979512\t217630777 EUP2510X\t00643169560000\t217668157 EUP2510X\t00643169618732\t217721598 EUP2510X\t00643169979512\t217765233 EUP2510X\t00643169560000\t217766421 EUP2510X\t00643169560000\t217842269 EUP2510X\t00643169979512\t217940329 EUP2512X\t00643169979598\t217225193 EUP2512X\t00643169979598\t217253645 EUP2512X\t00643169979598\t217282161 EUP2512X\t00643169979598\t217291126 EUP2512X\t00643169560017\t217313594 EUP2512X\t00643169560017\t217325278 EUP2512X\t00643169560017\t217339176 EUP2512X\t00643169560017\t217347760 EUP2512X\t00643169560017\t217371292 EUP2512X\t00643169979598\t217385685 EUP2512X\t00643169618817\t217396345 EUP2512X\t00643169560017\t217404066 EUP2512X\t00643169560017\t217435216 EUP2512X\t00643169979598\t217444058 EUP2512X\t00643169618817\t217444065 EUP2512X\t00643169560017\t217465241 EUP2512X\t00643169979598\t217451083 EUP2512X\t00643169618817\t217451570 EUP2512X\t00643169979598\t217473912 EUP2512X\t00643169979598\t217480327 EUP2512X\t00643169560017\t217488907 EUP2512X\t00643169560017\t217506606 EUP2512X\t00643169560017\t217526982 EUP2512X\t00643169560017\t217535681 EUP2512X\t00643169979598\t217584298 EUP2512X\t00643169979598\t217601081 EUP2512X\t00643169979598\t217616449 EUP2512X\t00643169979598\t217630782 EUP2512X\t00643169560017\t217638062 EUP2512X\t00643169560017\t217656456 EUP2512X\t00643169560017\t217675571 EUP2512X\t00643169560017\t217705253 EUP2512X\t00643169560017\t217713358 EUP2512X\t00643169979598\t217762421 EUP2512X\t00643169979598\t217765228 EUP2512X\t00643169979598\t217791233 EUP2512X\t00643169560017\t217791031 EUP2512X\t00643169618817\t217791227 EUP2512X\t00643169618817\t217803297 EUP2512X\t00643169618817\t217832636 EUP2512X\t00643169979598\t217876355 EUP2512X\t00643169560017\t217875835 EUP2512X\t00643169560017\t217884491 EUP2512X\t00643169979598\t217891540 EUP2512X\t00643169560017\t217905889 EUP2515X\t00643169979215\t217253667 EUP2515X\t00643169979215\t217262908 EUP2515X\t00643169979215\t217270931 EUP2515X\t00643169979215\t217282163 EUP2515X\t00643169618435\t217291130 EUP2515X\t00643169979215\t217291004 EUP2515X\t00643169560024\t217325276 EUP2515X\t00643169560024\t217339175 EUP2515X\t00643169560024\t217347822 EUP2515X\t00643169979215\t217379611 EUP2515X\t00643169979215\t217385683 EUP2515X\t00643169979215\t217396794 EUP2515X\t00643169560024\t217402505 EUP2515X\t00643169560024\t217418947 EUP2515X\t00643169979215\t217444059 EUP2515X\t00643169979215\t217451081 EUP2515X\t00643169560024\t217465240 EUP2515X\t00643169618435\t217473725 EUP2515X\t00643169979215\t217473908 EUP2515X\t00643169979215\t217480204 EUP2515X\t00643169618435\t217480205 EUP2515X\t00643169979215\t217499989 EUP2515X\t00643169618435\t217499990 EUP2515X\t00643169560024\t217535677 EUP2515X\t00643169560024\t217518424 EUP2515X\t00643169979215\t217557957 EUP2515X\t00643169979215\t217576085 EUP2515X\t00643169979215\t217584295 EUP2515X\t00643169979215\t217601080 EUP2515X\t00643169618435\t217602589 EUP2515X\t00643169979215\t217616452 EUP2515X\t00643169560024\t217656458 EUP2515X\t00643169560024\t217675572 EUP2515X\t00643169979215\t217713409 EUP2515X\t00643169979215\t217721600 EUP2515X\t00643169979215\t2177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"firm_fei_number": "3002806434", "recalling_firm": "Medtronic Vascular Galway DBA Medtronic Ireland", "address_1": "Parkmore Business Park West", "city": "Galway", "country": "Ireland", "additional_info_contact": "Wendy Dougherty\n707-541-3004", "reason_for_recall": "Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.", "root_cause_description": "Under Investigation by firm", "action": "Medtronic notified it consignees by letter beginning on 09/03/2019. The firm requested the return of the affected product.", "product_quantity": "53137 units", "distribution_pattern": "worldwide", "openfda": { "k_number": [ "K211349", "K143480", "K223022", "K133633", "K173680", "K170941", "K222538", "K230705", "K152485", "K121222", "K896108", "K162625", "K172264", "K211393", "K252116", "K220629", "K861847", "K113220", "K150292", "K162209", "K110133", "K252295", "K103657", "K251970", "K113464", "K123473", "K110134", "K141933", "K182699", "K820410", "K111284", "K203390", "K230374", "K162434", "K143160", "K181023", "K134031", "K160961", "K843944", "K130391", "K131169", "K103808", "K153682", "K220634", "K233729", "K163174", "K212393", "K163114", "K163200", "K141236", "K112735", "K202578", "K233499", "K133852", "K233505", "K103110", "K180921", "K103153", "K141025", "K211807", "K210012", "K121196", "K200269", "K123279", "K254022", "K141090", "K110617", "K242969", "K111544", "K123264", "K131450", "K163660", "K113775", "K261759", "K121681", "K103095", "K163372", "K160823", "K202619", "K173581", "K153742", "K180040", "K223189", "K121667", "K160985", "K192344", "K122178" ], "pma_number": [ "P950020", "P910031", "P960014", "P970052", "P790017", "P930012", "P880027", "P890032", "P850021", "P020037", "P880055", "P890048", "P860019", "P990008", "P890001", "P840040", "P810046", "P870036", "P880065", "P880003", "P940009", "P870021" ], "registration_number": [ "3003898360", "", "3013546453", "3009205152", "3009613036", "3035111606", "3013634084", "3003775186", "3002807315", "2939561", "9681260", "3004415014", "3008002401", "3030421123", "3004824117", "9710284", "3017961114", "9612164", "3012050423", "3014461810", "8043892", "3002807314", "1225687", "3012167431", "3013341368", "2011171", "2124215", "3004091615", "1721686", "3010131137", "3019807891", "3008824097", "3007836437", "2134265", "3015002281", "3014656749", "9681834", "3044156918", "3013944123", "3010432890", "1000121056", "3010273872", "3014390222", "3009965866", "3009018440", "3015453963", "3011564431", "3015910259", "3010220595", "2183744", "3034695832", "3012693555", "9614654", "3006550224", "3010391265", "3003084171", "9617601", "3024893679", "3031550970", "3011137372", "3006513822", "1313046", "3030236028", "2024168", "3018805824", "2134812", "3043534762", "3007156625", "3014222368", "3016678045", "1319639", "3017262662", "8010026", "1422634", "3009564766", "3008573567", "3013152301", "3008700817", "3006946276", "1028232" ], "fei_number": [ "3003898360", "", "3013546453", "3009205152", "3002808327", "3009613036", "3035111606", "3013634084", "3003775186", "3002807315", "3004415014", "3008002401", "3002806565", "3005747797", "3030421123", "3004824117", "3017961114", "3008133910", "3012050423", "3014461810", "3004635528", "3002807314", "3002534070", "1000138054", "3012167431", "3013341368", "3002095335", "2011171", "3002806434", "2124215", "1000514656", "3004091615", "3002827704", "1721686", "3010131137", "3019807891", "3008824097", "3007836437", "3001451463", "3015002281", "3014656749", "3044156918", "3013944123", "3010432890", "1000121056", "3010273872", "3014390222", "3009965866", "3009018440", "3015453963", "3011564431", "3015910259", "3010220595", "2183744", "3034695832", "3012693555", "3002808904", "3002808050", "3006550224", "3010391265", "3003084171", "3003182398", "3024893679", "3031550970", "3006513822", "1313046", "3030236028", "2024168", "3018805824", "3043534762", "3014222368", "3016678045", "3017262662", "3009564766", "2828", "3008573567", "3013152301", "3008700817", "3006946276", "1028232" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ] }