{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "197399", "product_res_number": "Z-0911-2023", "event_date_initiated": "2022-12-03", "event_date_posted": "2023-01-06", "recall_status": "Open, Classified", "res_event_number": "91296", "product_code": "LGW", "product_description": "Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A", "code_info": "GTIN 00643169890923: Serial/Lot Numbers: NPL0000474, NPL0000027, NPL0000072, NPL0000284, NPL0000561, NPL0003519, NPL0003792, NPL0000454, NPL0002036, NPL0004205, NPL0004222, NPL0003112, NPL0001300, NPL0003989, NPL0004099, NPL0004693, NPL0004711, NPL0004761, NPL0003189, NPL0001861, NPL0000740, NPL0001082, NPL0001698, NPL0001700, NPL0001703, NPL0003058, NPL0001697, NPL0003428, NPL0004076, NPL0001735, NPL0000971, NPL0002467, NPL0001025, NPL0000012, NPL0004605, NPL0002212, NPL0003070, NPL0000966, NPL0003890, NPL0001326, NPL0002948, NPL0000300, NPL0001081, NPL0003246, NPL0000325, NPL0000095, NPL0000756, NPL0002660, NPL0001100, NPL0002921, NPL0000548, NPL0000018, NPL0000170, NPL0003125, NPL0000495, NPL0003562, NPL0002336, NPL0002674, NPL0003293, NPL0003324, NPL0001498, NPL0004017, NPL0004018, NPL0000270, NPL0001652, NPL0001778, NPL0001937, NPL0001939, NPL0001940, NPL0001951, NPL0001990, NPL0002001, NPL0002380, NPL0002705, NPL0002913, NPL0003064, NPL0003516, NPL0003517, NPL0003530, NPL0003532, NPL0003599, NPL0003642, NPL0003643, NPL0004014, NPL0004890, NPL0004892, NPL0000470, NPL0003793, NPL0000391, NPL0000279, NPL0001050, NPL0000390, NPL0002715, NPL0001728, NPL0001730, NPL0003212, NPL0002174, NPL0004842, NPL0001060, NPL0000713, NPL0001079, NPL0000308, NPL0003196, NPL0003625, NPL0003197, NPL0004404, NPL0002896, NPL0003831, NPL0001059, NPL0003796, NPL0001042, NPL0002710, NPL0003235, NPL0004126, NPL0002552, NPL0000225, NPL0001400, NPL0003998, NPL0004153, NPL0002046, NPL0001084, NPL0001111, NPL0002053, NPL0002059, NPL0003820, NPL0004501, NPL0004502, NPL0004795, NPL0004799, NPL0004800, NPL0001708, NPL0003198, NPL0000466, NPL0002530, NPL0002544, NPL0000742, NPL0001651, NPL0004003, NPL0004698, NPL0002176, NPL0003478, NPL0001624, NPL0001879, NPL0004477, NPL0004482, NPL0001692, NPL0004910, NPL0004363, NPL0003474, NPL0001064, NPL0001090, NPL0001603, NPL0001619, NPL0001667, NPL0001713, NPL0004364, NPL0004606, NPL0004701, NPL0002627, NPL0000043, NPL0002607, NPL0002626, NPL0004160, NPL0002554, NPL0002555, NPL0000980, NPL0001216, NPL0000221, NPL0003959, NPL0001707, NPL0004846, NPL0004058, NPL0003749, NPL0003210, NPL0001241, NPL0001246, NPL0001288, NPL0002648, NPL0003234, NPL0003241, NPL0002556, NPL0003222, NPL0001238, NPL0001258, NPL0002480, NPL0003292, NPL0001661, NPL0001662, NPL0001789, NPL0003283, NPL0003815, NPL0003947, NPL0001321, NPL0002565, NPL0004621, NPL0004652, NPL0001240, NPL0002657, NPL0002658, NPL0001271, NPL0003071, NPL0001718, NPL0002711, NPL0002712, NPL0001274, NPL0002610, NPL0004906, NPL0001017, NPL0003997, NPL0004023, NPL0003462, NPL0002401, NPL0002403, NPL0001716, NPL0001717, NPL0004904, NPL0002462, NPL0004893, NPL0004894, NPL0004896, NPL0002846, NPL0002848, NPL0001591, NPL0003490, NPL0001270, NPL0001028, NPL0002696, NPL0002773, NPL0001768, NPL0001466, NPL0001289, NPL0001791, NPL0004662, NPL0001245, NPL0003986, NPL0001208, NPL0001209, NPL0001272, NPL0001239, NPL0001053, NPL0001055, NPL0002891, NPL0001333, NPL0001345, NPL0002659, NPL0002725, NPL0003975, NPL0003329, NPL0002304, NPL0001828, NPL0001829, NPL0001275, NPL0002477, NPL0004801, NPL0002196, NPL0004149, NPL0004783, NPL0004784, NPL0002536, NPL0001242, NPL0001276, NPL0002944, NPL0002946, NPL0002947, NPL0002985, NPL0003459, NPL0002413, NPL0003737, NPL0004162, NPL0003200, NPL0002019, NPL0001231, NPL0004016, NPL0004577, NPL0002326, NPL0004494, NPL0004520, NPL0001612, NPL0003601, NPL0003602, NPL0004521, NPL0004674, NPL0002016, NPL0002133, NPL0003372, NPL0004274, NPL0003063, NPL0003228, NPL0003240, NPL0003208, NPL0001252, NPL0001478, NPL0002039, NPL0003784, NPL0003800, NPL0001296, NPL0001312, NPL0001314, NPL0001317, NPL0001318, NPL0001319, NPL0002428, NPL0003059, NPL0003463, NPL0003464, NPL0003466, NPL0004202, NPL0001373, NPL0001383, NPL0001384, NPL0001394, NPL0001396, NPL0001501, NPL0003838, NPL0002895, NPL0002969, NPL0003122, NPL0003458, NPL0004050, NPL0001441, NPL0001445, NPL0001051, NPL0001315, NPL0001316, NPL0001674, NPL0001819, NPL0004221, NPL0004601, NPL0001393, NPL0001083, NPL0003094, NPL0003095, NPL0003096, NPL0003341, NPL0003460, NPL0003992, NPL0004060, NPL0003188, NPL0001540, NPL0002008, NPL0002540, NPL0002541, NPL0002640, NPL0002706, NPL0001105, NPL0002548, NPL0002561, NPL0002667, NPL0002668, NPL0003715, NPL0003716, NPL0003763, NPL0004377, NPL0001070, NPL0001099, NPL0001571, NPL0001926, NPL0003179, NPL0003190, NPL0003973, NPL0003974, NPL0004052, NPL0004532, NPL0004533, NPL0001259, NPL0003269, NPL0001061, NPL0001106, NPL0001378, NPL0001403, NPL0001414, NPL0004011, NPL0004609, NPL0004668, NPL0004680, NPL0001171, NPL0001821, NPL0001822, NPL0001823, NPL0001812, NPL0003172, NPL0003174, NPL0003175, NPL0003272, NPL0003720, NPL0003205, NPL0003217, NPL0001291, NPL0003777, NPL0001817, NPL0002823, NPL0003346, NPL0003983, NPL0004107, NPL0004118, NPL0004370, NPL0001530, NPL0002577, NPL0002824, NPL0004105, NPL0001759, NPL0001813, NPL0001814, NPL0001815, NPL0001818, NPL0001854, NPL0003369, NPL0004037, NPL0001301, NPL0001302, NPL0001307, NPL0001308, NPL0001310, NPL0001311, NPL0001328, NPL0001329, NPL0001355, NPL0001938, NPL0001253, NPL0002436, NPL0002437, NPL0003252, NPL0002522, NPL0002738, NPL0004312, NPL0004314, NPL0004316, NPL0001950, NPL0001976, NPL0002000, NPL0002003, NPL0001137, NPL0001013, NPL0001074, NPL0001075, NPL0001009, NPL0000743, NPL0000746, NPL0000554, NPL0000051", "firm_fei_number": "2182207", "recalling_firm": "Medtronic Neuromodulation", "address_1": "7000 Central Ave Ne", "city": "Minneapolis", "state": "MN", "postal_code": "55432-3568", "additional_info_contact": "Michelle Claypool\n763-526-9452", "reason_for_recall": "Software anomalies, CP App messages: \"Too Many Device Found\", \"Unexpected Device Error Code 1502\", and \"System Update Needed, Service Code 303\"", "root_cause_description": "Under Investigation by firm", "action": "The firm issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/03/2022 by mail. The notices explained the problems and the associated risks and provided the following: \n\"Recommended Mitigation\nIf the INS cannot be interrogated with Vanta PP App, contact Medtronic Technical Services at 1-800-707-0933. If needed, Medtronic will schedule an in-field service appointment with the managing SCS physician and the patient to diagnose and reset the INS.\" \n\"Medtronic is working on a Vanta CP App software update that will resolve this issue and will communicate additional information when it becomes available.\"", "product_quantity": "440 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "pma_number": [ "P030017", "P130028", "P010032", "P130022", "P190002", "P210037", "P800040", "P840001" ], "registration_number": [ "9681477", "3008988055", "2135338", "3021836309", "3010052483", "3015200795", "2182207", "3009380063", "2648729", "3019807891", "3015924373", "2133641", "3013023969", "2124215", "3010966701", "3010972758", "2183744", "1035166", "1928237", "3008514029", "3014507028", "3003120897", "3016618265", "3003477135", "3006630150", "3020969413", "3005210579", "3027063190", "3005160949", "3007882731", "2182291", "3010326622", "3004593495", "2134604", "3010531069", "3004519921", "3003335547", "9610139", "2133810", "3013973539", "3018094310", "1627487", "3004209178", "2133772", "2024311", "2030624", "3007616088", "3038429246", "9616693", "3010086866", "2649622", "3006705815", "3013368220", "3012693387", "2032521", "3015173212" ], "fei_number": [ "3002806500", "3008988055", "3021836309", "3010052483", "3015200795", "2182207", "3009380063", "3005846326", "3005700659", "2648729", "3002618605", "3000206435", "3019807891", "3015924373", "3013023969", "2124215", "3010966701", "3010972758", "2183744", "1035166", "3000203466", "1928237", "3008514029", "3014507028", "3003120897", "3016618265", "3003477135", "3000209794", "3006630150", "3020969413", "3005210579", "3027063190", "3005160949", "3007882731", "2182291", "3010326622", "3004593495", "3010531069", "3003335547", "3002623849", "3013973539", "3018094310", "1627487", "2024311", "3000203066", "3007616088", "3038429246", "3003574398", "2649622", "3010086866", "3002807439", "3006705815", "3013368220", "3012693387", "3004369318", "3015173212" ], "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }