{ "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": "159836", "product_res_number": "Z-0685-2018", "event_date_initiated": "2017-11-06", "event_date_posted": "2018-02-22", "recall_status": "Open, Classified", "res_event_number": "78587", "product_code": "NIP", "pma_numbers": [ "P140028" ], "product_description": "Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows:\n\nProduct Usage:\nThe Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm.\n \n\na. H74939293052030 (Material Description Innova 5 x 200 x 130); \nb. H74939293052070 (Material Description Innova 5 x 200 x 75); \nc. H74939293062030 (Material Description Innova 6 x 200 x 130); \nd. H74939293062070 (Material Description Innova 6 x 200 x 75); \ne. H74939293072030 (Material Description Innova 7 x 200 x 130); \nf. H74939293072070 (Material Description Innova 7 x 200 x 75); \ng. H74939293082030 (Material Description Innova 8 x 200 x 130); \nh. H74939293082070 (Material Description Innova 8 x 200 x 75)", "code_info": "a. Innova 5 x 200 x 130 (Batch No. 18095733, 18137885, 18233108, 18379812, 18362996, 18420576, 18404859, 18457350, 18478823, 18488703, 18519986, 18696468, 18670333, 18667082, 18756979, 18855752, 18844729, 18872178, 18886680, 18866631, 18892405, 18900294, 18951278, 19039704, 19064055, 19079251, 19111601, 19173251, 19206070, 19238815, 19231426, 19351863, 19309202, 19382422, 19367647, 19426956, 19483869, 19490837, 19501322, 19540549, 19540559, 19569664, 19641827, 19750808, 19742326, 19830060, 19844547, 19873365, 19907333, 19970577, 20014162, 20080095, 20096498, 20112175, 20186872, 20223208, 20216043, 20435880, 20151952, 20444934, 20439618, 20314154, 20336209, 20394072, 20608020, 20608137, 20607734, 20657170, 20420612, 20337854, 20450027, 20616298, 20777472, 20470018, 20672513, 20832034, 20876897, 20871401, 20728970, 20776633, 20851808, 20975844, 21020806, 21124105, 21045072, 21057925, 21091417, 21115593);  b. Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110);  c. Innova 6 x 200 x 130 (Batch No. 18152540, 18137923, 18096697, 18119044, 18119040, 18115810, 18230863, 18108301, 18230864, 18211280, 18211281, 18245462, 18230637, 18230636, 18410450, 18428643, 18473268, 18283383, 18343799, 18439907, 18431333, 18368130, 18523235, 18519980, 18661526, 18488709, 18389662, 18498563, 18515152, 18446693, 18733063, 18759192, 18759189, 18766678, 19540741, 18791863, 18832544, 18792872, 18855754, 18860236, 18823216, 18866636, 18844738, 18892194, 18900365, 18870948, 18872541, 18878446, 18900381, 18888435, 18988348, 18961203, 19064043, 18945808, 19072771, 19111551, 19079253, 19151922, 19116475, 19164618, 19206072, 19226126, 19141574, 19245284, 19240145, 19288826, 19288832, 19309205, 19309206, 19367648, 19377502, 19408962, 19426948, 19389007, 19490838, 19511466, 19501332, 19517646, 19545788, 19555598, 19560848, 19569663, 19589370, 19584757, 19641826, 19635253, 19664685, 19654162, 19670616, 19709446, 19728413, 19699320, 19782868, 19693686, 19682956, 19682955, 19830064, 19873362, 19907334, 19905446, 19941738, 19942503, 19918783, 20013959, 19970579, 20014164, 20023939, 20109861, 20188996, 20080098, 20080097, 20188052, 20187538, 20080096, 20109863, 20112179, 20320562, 20830984, 20216045, 20183756, 20158213, 20433364, 20434473, 20233669, 20286988, 20233670, 20303729, 20342627, 20233668, 20607288, 20574727, 20607402, 20455108, 20368051, 20432603, 20511193, 20394775, 20594724, 20635843, 20776979, 20478648, 20821884, 20754076, 20758252, 20821886, 20800469, 20886809, 20825353, 20885852, 20938124, 20913156, 20950528, 20975845, 20997424, 21004412, 21119055, 21117395, 21058225, 21098042, 21071017, 21122202, 21145025, 21145024, 21219047, 21219242, 21219052);  d. Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043);  e. Innova 7 x 200 x 130 (Batch No. 18152541, 18099223, 18130828, 18113523, 18230638, 18217571, 18211282, 18186723, 18240225, 18168041, 18291418, 18339045, 18368242, 18283384, 18339044, 18316737, 18394605, 18385509, 18420569, 18313150, 18488713, 18921110, 18961213, 19072776, 19134318, 19173258, 19161488, 19206078, 19228862, 19255680, 19288830, 19309211, 19377507, 19327253, 19408970, 19436702, 19483875, 19491821, 19501423, 19527344, 19555961, 19545789, 19624864, 19659433, 19693528, 19670619, 19709445, 19830069, 19811429, 19742336, 19918785, 19907336, 19851529, 19974524, 19974523, 20080094, 20001802, 20109860, 20001803, 20188364, 20109862, 20177945, 20181650, 20210393, 20244728, 20321275, 20320380, 20286989, 20434033, 20267930, 20405389, 20381126, 20316570, 20574731, 20607286, 20352590, 20442151, 20466869, 20622461, 20655052, 20495971, 20518171, 20628127, 20777268, 20777261, 20820730, 20731022, 20833824, 20758256, 20886953, 20819295, 20856506, 20910181, 20937554, 21004415, 21119514, 20997428, 21119515, 21045505, 21103020, 21058247, 21138682, 21217652);  f. Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996);  g. Innova 8 x 200 x 130 (Batch No. 18211294, 18313156, 18385119, 18519981, 18583365, 18611781, 18733076, 18754584, 18780335, 18844724, 18977671, 19006855, 19048092, 19072779, 19188060, 19245289, 19304348, 19351866, 19454525, 19501424, 19624788, 19664694, 19684647, 19839023, 19782933, 20014160, 20080099, 20112342, 20216047, 20286991, 20439603, 20386608, 20655679, 20655677, 20329707, 20410534, 20655798, 20357647, 20997431, 21123358, 21123667);  h. Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "2 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "Nicole Pshon\n763-494-1133", "reason_for_recall": "Stent possibly unable to be fully released from the delivery system.", "root_cause_description": "Nonconforming Material/Component", "action": "Boston Scientific sent an Urgent Medical Device letter dated November 6, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers\\ were instructed to immediately discontinue use of the product and remove all affected products from inventory, complete and return the Verification Form, return affected products and provide the notification to any healthcare professionals affected.", "product_quantity": "22,916 units total", "distribution_pattern": "Worldwide Distribution - US Nationwide \n\nDistributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV. \n\nDistributed internationally to Canada", "openfda": { "pma_number": [ "P070014", "P110040", "P040037", "P000033", "P110023", "P160025", "P120002", "P140002", "P180003", "P160004", "P120020", "P140028", "P050017" ], "registration_number": [ "3009526575", "9681442", "3014656749", "3011632150", "1643817", "3004091615", "3002504068", "3010155661", "1048735", "1225687", "3010273872", "9616099", "3011574793", "9681260", "2134265", "2183744", "3001845648", "2124215", "3002807314", "2939561", "2183870", "3008328690", "2017233", "8010026", "1721676", "1721686", "2024168", "2020394", "3010220595", "1000121056", "3010432890", "3006946276", "9681834", "3005941719", "3005580113", "8043892", "2011171", "1016427", "3002807090" ], "fei_number": [ "3002095335", "3009526575", "3011632150", "1643817", "3004091615", "3002806368", "3002504068", "3006003617", "3010155661", "1048735", "3010273872", "2828", "3011574793", "3004635528", "3001845648", "2183744", "3002808327", "2124215", "3002807314", "2183870", "3008328690", "2017233", "1721676", "1721686", "2024168", "3002808050", "2020394", "3010220595", "3002806565", "1000121056", "3010432890", "3003528016", "3006946276", "3002807111", "3005580113", "3001451463", "2011171", "1016427", "3014656749" ], "device_name": "Stent, Superficial Femoral Artery", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }