{ "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": "176382", "product_res_number": "Z-0123-2020", "event_date_initiated": "2019-09-03", "event_date_created": "2019-10-11", "recall_status": "Open, Classified", "res_event_number": "83797", "product_code": "LOX", "product_description": "Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)", "code_info": "Product Number / CFN\tGTIN\tLot SLC1506X\t00643169680005\t217427355 SLC1510X\t00643169680012\t217253572 SLC1510X\t00643169680012\t217298666 SLC1510X\t00643169680012\t217387126 SLC1510X\t00643169680012\t217427354 SLC1510X\t00643169680012\t217487816 SLC1512X\t00643169680029\t217218112 SLC1512X\t00643169680029\t217253582 SLC1512X\t00643169680029\t217387128 SLC1512X\t00643169680029\t217487818 SLC1512X\t00643169680029\t217542634 SLC1512X\t00643169680029\t217859789 SLC1515X\t00643169680036\t217246455 SLC1515X\t00643169680036\t217253577 SLC1515X\t00643169680036\t217306789 SLC1515X\t00643169680036\t217415822 SLC1515X\t00643169680036\t217427365 SLC1515X\t00643169680036\t217823443 SLC1515X\t00643169680036\t217859165 SLC1515X\t00643169680036\t217940024 SLC1520X\t00643169680043\t217253580 SLC1520X\t00643169680043\t217306787 SLC1520X\t00643169680043\t217427359 SLC1520X\t00643169680043\t217542633 SLC1520X\t00643169680043\t217646425 SLC1520X\t00643169680043\t217668582 SLC1520X\t00643169680043\t217799249 SLC1520X\t00643169680043\t217859164 SLC2006X\t00643169680050\t217435326 SLC2006X\t00643169680050\t217913786 SLC2010X\t00643169680067\t217253573 SLC2010X\t00643169680067\t217297545 SLC2010X\t00643169680067\t217387127 SLC2010X\t00643169680067\t217427356 SLC2010X\t00643169680067\t217646867 SLC2010X\t00643169680067\t217668585 SLC2010X\t00643169680067\t217676631 SLC2010X\t00643169680067\t217905820 SLC2012X\t00643169680074\t217253578 SLC2012X\t00643169680074\t217298670 SLC2012X\t00643169680074\t217306788 SLC2012X\t00643169680074\t217415824 SLC2012X\t00643169680074\t217434925 SLC2012X\t00643169680074\t217602539 SLC2012X\t00643169680074\t217668687 SLC2012X\t00643169680074\t217799250 SLC2012X\t00643169680074\t217859791 SLC2012X\t00643169680074\t217940066 SLC2015X\t00643169680081\t217218115 SLC2015X\t00643169680081\t217253574 SLC2015X\t00643169680081\t217271254 SLC2015X\t00643169680081\t217298669 SLC2015X\t00643169680081\t217306223 SLC2015X\t00643169680081\t217404046 SLC2015X\t00643169680081\t217418812 SLC2015X\t00643169680081\t217418907 SLC2015X\t00643169680081\t217427706 SLC2015X\t00643169680081\t217435327 SLC2015X\t00643169680081\t217498815 SLC2015X\t00643169680081\t217615647 SLC2015X\t00643169680081\t217646871 SLC2015X\t00643169680081\t217668584 SLC2015X\t00643169680081\t217713076 SLC2015X\t00643169680081\t217721607 SLC2015X\t00643169680081\t217777612 SLC2015X\t00643169680081\t217799251 SLC2015X\t00643169680081\t217884509 SLC2015X\t00643169680081\t217913790 SLC2020X\t00643169680098\t217218110 SLC2020X\t00643169680098\t217246457 SLC2020X\t00643169680098\t217253575 SLC2020X\t00643169680098\t217271253 SLC2020X\t00643169680098\t217298667 SLC2020X\t00643169680098\t217306220 SLC2020X\t00643169680098\t217387130 SLC2020X\t00643169680098\t217404047 SLC2020X\t00643169680098\t217418908 SLC2020X\t00643169680098\t217487822 SLC2020X\t00643169680098\t217498821 SLC2020X\t00643169680098\t217676628 SLC2020X\t00643169680098\t217713075 SLC2020X\t00643169680098\t217727927 SLC2020X\t00643169680098\t217799252 SLC2020X\t00643169680098\t217850364 SLC2020X\t00643169680098\t217905822 SLC2025X\t00643169680104\t217271251 SLC2025X\t00643169680104\t217542635 SLC2025X\t00643169680104\t217905821 SLC2030X\t00643169680111\t217218119 SLC2030X\t00643169680111\t217427363 SLC2030X\t00643169680111\t217602538 SLC2030X\t00643169680111\t217704778 SLC2030X\t00643169680111\t217777614 SLC22510X\t00643169680135\t217487815 SLC22510X\t00643169680135\t217646423 SLC22515X\t00643169680159\t217427362 SLC22515X\t00643169680159\t217646422 SLC22520X\t00643169680166\t217721606 SLC22520X\t00643169680166\t217913787 SLC22525X\t00643169680173\t217415820 SLC22525X\t00643169680173\t218025488 SLC2506X\t00643169680180\t217823441 SLC2510X\t00643169680197\t217218122 SLC2510X\t00643169680197\t217401003 SLC2510X\t00643169680197\t217427357 SLC2510X\t00643169680197\t217693881 SLC2510X\t00643169680197\t217913792 SLC2510X\t00643169680197\t218034774 SLC2512X\t00643169680203\t217271257 SLC2512X\t00643169680203\t217306225 SLC2512X\t00643169680203\t217415825 SLC2512X\t00643169680203\t217434924 SLC2512X\t00643169680203\t217498822 SLC2512X\t00643169680203\t217606584 SLC2512X\t00643169680203\t217695006 SLC2512X\t00643169680203\t217859787 SLC2512X\t00643169680203\t217913793 SLC2515X\t00643169680210\t217253581 SLC2515X\t00643169680210\t217306786 SLC2515X\t00643169680210\t217401005 SLC2515X\t00643169680210\t217418813 SLC2515X\t00643169680210\t217418906 SLC2515X\t00643169680210\t217427709 SLC2515X\t00643169680210\t217487819 SLC2515X\t00643169680210\t217498813 SLC2515X\t00643169680210\t217542636 SLC2515X\t00643169680210\t217602540 SLC2515X\t00643169680210\t217646866 SLC2515X\t00643169680210\t217693884 SLC2515X\t00643169680210\t217859788 SLC2515X\t00643169680210\t217905823 SLC2515X\t00643169680210\t218045287 SLC2520X\t00643169680227\t217271256 SLC2520X\t00643169680227\t217387129 SLC2520X\t00643169680227\t217404048 SLC2520X\t00643169680227\t217418909 SLC2520X\t00643169680227\t217434922 SLC2520X\t00643169680227\t217487821 SLC2520X\t00643169680227\t217498819 SLC2520X\t00643169680227\t217542632 SLC2520X\t00643169680227\t217646868 SLC2520X\t00643169680227\t217695009 SLC2520X\t00643169680227\t217859162 SLC2520X\t00643169680227\t217913794 SLC2525X\t00643169680234\t217218108 SLC2525X\t00643169680234\t217675585 SLC2530X\t00643169680241\t217246456 SLC2530X\t00643169680241\t217434923 SLC2530X\t00643169680241\t217498814 SLC2530X\t00643169680241\t217615649 SLC2530X\t00643169680241\t217704782 SLC2530X\t00643169680241\t217777613 SLC27512X\t00643169680265\t217427360 SLC27512X\t00643169680265\t217602535 SLC27512X\t00643169680265\t217695007 SLC27512X\t00643169680265\t217850362 SLC27515X\t00643169680272\t217542631 SLC27515X\t00643169680272\t217602534 SLC27515X\t00643169680272\t217646421 SLC27515X\t00643169680272\t217713071 SLC27515X\t00643169680272\t217799248 SLC27520X\t00643169680289\t217298668 SLC27520X\t00643169680289\t217387131 SLC27520X\t00643169680289\t217704783 SLC27520X\t00643169680289\t217832948 SLC3010X\t00643169680319\t217271255 SLC3010X\t00643169680319\t217693880 SLC3010X\t00643169680319\t217850363 SLC3012X\t00643169680326\t217306224 SLC3012X\t00643169680326\t217415821 SLC3012X\t00643169680326\t217498812 SLC3012X\t00643169680326\t217646869 SLC3012X\t00643169680326\t217704781 SLC3012X\t00643169680326\t217850360 SLC3015X\t00643169680333\t217246458 SLC3015X\t00643169680333\t217253579 SLC3015X\t00643169680333\t217306790 SLC3015X\t00643169680333\t217418910 SLC3015X\t00643169680333\t217498816 SLC3015X\t00643169680333\t217615646 SLC3015X\t00643169680333\t217693885 SLC3015X\t00643169680333\t217832949 SLC3015X\t00643169680333\t217913791 SLC3020X\t00643169680340\t217253571 SLC3020X\t00643169680340\t217297544 SLC3020X\t00643169680340\t217306222 SLC3020X\t00643169680340\t217401004 SLC3020X\t00643169680340\t217498818 SLC3020X\t00643169680340\t217646872 SLC3020X\t00643169680340\t217695008 SLC3020X\t00643169680340\t217859163 SLC3025X\t00643169680357\t217306221 SLC3025X\t00643169680357\t217487817 SLC3030X\t00643169680364\t217218124 SLC3030X\t00643169680364\t217427708 SLC3030X\t00643169680364\t217602537 SLC3030X\t00643169680364\t217850358 SLC3506X\t00643169680401\t217246454 SLC3506X\t00643169680401\t217713072 SLC3510X\t00643169680418\t217668583 SLC3512X\t00643169680425\t217913789 SLC3515X\t00643169680432\t217271252 SLC3515X\t00643169680432\t217415823 SLC3515X\t00643169680432\t217498817 SLC3515X\t00643169680432\t217668580 SLC3515X\t00643169680432\t217913788 SLC3520X\t00643169680449\t217646424 SLC3520X\t00643169680449\t217676626 SLC3520X\t00643169680449\t217832947 SLC3520X\t00643169680449\t217850361 SLC3530X\t00643169680463\t217940068 SLC4010X\t00643169680517\t217246459 SLC4012X\t00643169680524\t217668581 SLC4012X\t00643169680524\t217905819 SLC4015X\t00643169680531\t217498820 SLC4015X\t00643169680531\t217615648 SLC4015X\t00643169680531\t217859790 SLC4020X\t00643169680548\t217427353 SLC4020X\t00643169680548\t217487820 SLC4020X\t00643169680548\t217606585 SLC4025X\t00643169680555\t217823440 SLC4030X\t00643169680562\t217823444", "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": "98675 units", "distribution_pattern": "worldwide", "openfda": { "k_number": [ "K896108", "K123264", "K252116", "K110133", "K153742", "K150292", "K212393", "K133633", "K820410", "K251970", "K861847", "K162209", "K123279", "K163174", "K220634", "K180040", "K242969", "K121196", "K180921", "K110617", "K261428", "K103095", "K153682", "K163114", "K141236", "K261759", "K121222", "K203390", "K121667", "K152485", "K220629", "K122178", "K211807", "K211393", "K141025", "K230374", "K141090", "K160823", "K160961", "K143480", "K141933", "K143160", "K130391", "K131450", "K113775", "K182699", "K233729", "K162625", "K181023", "K223189", "K160985", "K211349", "K134031", "K210012", "K111544", "K131169", "K223022", "K173581", "K843944", "K163200", "K103808", "K103153", "K112735", "K103110", "K163372", "K172264", "K133852", "K111284", "K202619", "K163660", "K123473", "K200269", "K170941", "K254022", "K162434", "K222538", "K192344", "K113464", "K230705", "K233499", "K121681", "K173680", "K233505", "K113220", "K202578", "K252295", "K103657", "K110134" ], "pma_number": [ "P990008", "P860019", "P880003", "P930012", "P870021", "P970052", "P790017", "P880027", "P950020", "P850021", "P890048", "P960014", "P910031", "P890032", "P940009", "P840040", "P880065", "P870036", "P810046", "P020037", "P880055", "P890001" ], "registration_number": [ "", "3010432890", "3011564431", "3015453963", "3009018440", "3002807315", "3004824117", "2124215", "3013152301", "3009965866", "8010026", "3006946276", "3014222368", "3016678045", "3006550224", "3008700817", "3013341368", "3002807314", "8043892", "3018805824", "2011171", "2134812", "1000121056", "1225687", "1721686", "3013546453", "3008824097", "3007156625", "3003898360", "3012693555", "3014461810", "3004091615", "3012050423", "3015002281", "3030421123", "3031550970", "2134265", "3004415014", "3003775186", "3008573567", "3030236028", "3013634084", "3014656749", "3008002401", "3017961114", "1313046", "1422634", "9617601", "3007836437", "2024168", "3010131137", "9681834", "3009205152", "3012167431", "9612164", "3044156918", "3024893679", "9614654", "3014390222", "3019807891", "3003084171", "3009564766", "3015910259", "3010220595", "3043534762", "2183744", "1319639", "1028232", "2939561", "3010273872", "9681260", "3006513822", "3013944123", "3011137372", "3009613036", "3017262662", "3035111606", "3010391265", "9710284", "3034695832" ], "fei_number": [ "", "3010432890", "3011564431", "3015453963", "1000138054", "3005747797", "3009018440", "3002807315", "3004824117", "3002808050", "3001451463", "2124215", "3013152301", "2828", "3009965866", "3002827704", "1000514656", "3006946276", "3002808904", "3002808327", "3014222368", "3002806434", "3016678045", "3006550224", "3008700817", "3013341368", "3002807314", "3018805824", "2011171", "1000121056", "1721686", "3013546453", "3008824097", "3003898360", "3012693555", "3002806565", "3014461810", "3004091615", "3012050423", "3015002281", "3030421123", "3031550970", "3004635528", "3004415014", "3003775186", "3008573567", "3008133910", "3030236028", "3013634084", "3014656749", "3008002401", "3017961114", "1313046", "3002095335", "3002534070", "3007836437", "2024168", "3010131137", "3009205152", "3012167431", "3044156918", "3024893679", "3014390222", "3019807891", "3003084171", "3009564766", "3003182398", "3015910259", "3010220595", "3043534762", "2183744", "1028232", "3010273872", "3006513822", "3013944123", "3009613036", "3017262662", "3035111606", "3010391265", "3034695832" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ] }