{ "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": "192467", "product_res_number": "Z-0998-2022", "event_date_initiated": "2022-02-28", "event_date_posted": "2022-04-22", "recall_status": "Open, Classified", "res_event_number": "89799", "product_code": "EZW", "pma_numbers": [ "P080025", "P970004" ], "product_description": "MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x \"My Therapy\" Patient Therapy Application Software, Model Number A52300", "code_info": "a) Model Numbers: \n1) TH90Q01, UDI-Device Identifier (GTIN/UPN) 00763000582470, Serial Numbers: NPF0000074, NPF0000075, NPF0000096, NPF0000097, NPF0000109, NPF0000197, NPF0000238, NPF0000263, NPF0000264, NPF0000270, NPF0000271, NPF0000284, NPF0000292, NPF0000379, NPF0000414, NPF0000422, NPF0000440, NPF0000458, NPF0000463, NPF0000480, NPF0000501, NPF0000515, NPF0000516, NPF0000517, NPF0000519, NPF0000537, NPF0000555, NPF0000618, NPF0000656, NPF0000691, NPF0000715, NPF0000784, NPF0000786, NPF0000828, NPF0000889, NPF0000908, NPF0000913, NPF0000915, NPF0000930, NPF0000931, NPF0001006, NPF0001045, NPF0001057, NPF0001058, NPF0001059, NPF0001060, NPF0001130, NPF0001135, NPF0001136, NPF0001154, NPF0001199, NPF0001267, NPF0001391, NPF0001403, NPF0001458, NPF0001485, NPF0001492, NPF0001493, NPF0001498, NPF0001502, NPF0001511, NPF0001620, NPF0001674, NPF0001713, NPF0001716, NPF0001758, NPF0001797, NPF0001824, NPF0001841, NPF0001868, NPF0001879, NPF0001893, NPF0001894, NPF0001900, NPF0001928, NPF0001931, NPF0002020, NPF0002025, NPF0002077, NPF0002078, NPF0002079, NPF0002102, NPF0002105, NPF0002117, NPF0002127, NPF0000060, NPF0000061, NPF0000063, NPF0000070, NPF0000099, NPF0000100, NPF0000116, NPF0000160, NPF0000291, NPF0000330, NPF0000465, NPF0000476, NPF0000477, NPF0000613, NPF0000614, NPF0000615, NPF0000617, NPF0000619, NPF0000654, NPF0000655, NPF0000690, NPF0000709, NPF0000711, NPF0000755, NPF0000756, NPF0000779, NPF0000804, NPF0000807, NPF0000823, NPF0000871, NPF0000880, NPF0000907, NPF0000977, NPF0000983, NPF0001000, NPF0001119, NPF0001145, NPF0001152, NPF0001158, NPF0001161, NPF0001188, NPF0001192, NPF0001208, NPF0001387, NPF0001456, NPF0001516, NPF0001554, NPF0001759, NPF0001781, NPF0002048, NPF0002076, NPF0002369, NPF0003037, NPF0003054, NPF0003386, NPF0000186, NPF0000222, NPF0000269, NPF0000289, NPF0000295, NPF0000296, NPF0000310, NPF0000319, NPF0000341, NPF0000766, NPF0001194, NPF0001209, NPF0001210, NPF0001213, NPF0001268, NPF0001278, NPF0001281, NPF0001291, NPF0001295, NPF0001319, NPF0001345, NPF0001357, NPF0001361, NPF0001362, NPF0001390, NPF0001420, NPF0001425, NPF0001555, NPF0001565, NPF0001618, NPF0001776, NPF0001898, NPF0001975, NPF0001984, NPF0002064, NPF0002080, NPF0002084, NPF0002085, NPF0002090, NPF0002144, NPF0002216, NPF0002229, NPF0002608, NPF0002622, NPF0002646, NPF0001820, NPF0001823, NPF0000064, NPF0000073, NPF0000085, NPF0000086, NPF0000088, NPF0000089, NPF0000091, NPF0000092, NPF0000095, NPF0000102, NPF0000103, NPF0000105, NPF0000107, NPF0000110, NPF0000117, NPF0000129, NPF0000130, NPF0000131, NPF0000150, NPF0000156, NPF0000158, NPF0000161, NPF0000172, NPF0000173, NPF0000174, NPF0000175, NPF0000176, NPF0000178, NPF0000179, NPF0000180, NPF0000181, NPF0000187, NPF0000192, NPF0000196, NPF0000198, NPF0000199, NPF0000203, NPF0000209, NPF0000210, NPF0000211, NPF0000212, NPF0000213, NPF0000214, NPF0000218, NPF0000221, NPF0000223, NPF0000234, NPF0000237, NPF0000244, NPF0000245, NPF0000246, NPF0000247, NPF0000248, NPF0000250, NPF0000256, NPF0000260, NPF0000266, NPF0000272, NPF0000277, NPF0000294, NPF0000298, NPF0000300, NPF0000301, NPF0000302, NPF0000303, NPF0000305, NPF0000309, NPF0000311, NPF0000312, NPF0000313, NPF0000320, NPF0000336, NPF0000340, NPF0000342, NPF0000345, NPF0000350, NPF0000353, NPF0000354, NPF0000357, NPF0000358, NPF0000364, NPF0000368, NPF0000369, NPF0000389, NPF0000393, NPF0000395, NPF0000397, NPF0000403, NPF0000404, NPF0000436, NPF0000438, NPF0000442, NPF0000447, NPF0000454, NPF0000459, NPF0000460, NPF0000461, NPF0000462, NPF0000471, NPF0000488, NPF0000497, NPF0000514, NPF0000518, NPF0000520, NPF0000521, NPF0000522, NPF0000524, NPF0000525, NPF0000526, NPF0000528, NPF0000530, NPF0000532, NPF0000539, NPF0000561, NPF0000564, NPF0000567, NPF0000568, NPF0000581, NPF0000587, NPF0000588, NPF0000606, NPF0000621, NPF0000623, NPF0000626, NPF0000638, NPF0000639, NPF0000643, NPF0000645, NPF0000650, NPF0000653, NPF0000657, NPF0000659, NPF0000660, NPF0000661, NPF0000676, NPF0000680, NPF0000683, NPF0000684, NPF0000686, NPF0000687, NPF0000689, NPF0000694, NPF0000704, NPF0000707, NPF0000712, NPF0000713, NPF0000714, NPF0000717, NPF0000720, NPF0000724, NPF0000728, NPF0000732, NPF0000737, NPF0000748, NPF0000750, NPF0000754, NPF0000758, NPF0000759, NPF0000761, NPF0000762, NPF0000763, NPF0000772, NPF0000775, NPF0000781, NPF0000783, NPF0000789, NPF0000794, NPF0000798, NPF0000805, NPF0000808, NPF0000809, NPF0000811, NPF0000812, NPF0000822, NPF0000824, NPF0000825, NPF0000826, NPF0000829, NPF0000830, NPF0000831, NPF0000832, NPF0000838, NPF0000840, NPF0000844, NPF0000846, NPF0000849, NPF0000863, NPF0000864, NPF0000865, NPF0000866, NPF0000868, NPF0000869, NPF0000870, NPF0000872, NPF0000882, NPF0000883, NPF0000886, NPF0000887, NPF0000890, NPF0000891, NPF0000892, NPF0000895, NPF0000903, NPF0000904, NPF0000906, NPF0000909, NPF0000911, NPF0000916, NPF0000918, NPF0000919, NPF0000920, NPF0000921, NPF0000923, NPF0000926, NPF0000928, NPF0000935, NPF0000948, NPF0000954, NPF0000959, NPF0000960, NPF0000962, NPF0000963, NPF0000965, NPF0000979, NPF0000980, NPF0000982, NPF0000993, NPF0000997, NPF0001001, NPF0001010, NPF0001018, NPF0001019, NPF0001024, NPF0001029, NPF0001031, NPF0001039, NPF0001040, NPF0001042, NPF0001044, NPF0001047, NPF0001049, NPF0001061, NPF0001062, NPF0001064, NPF0001067, NPF0001069, NPF0001070, NPF0001071, NPF0001072, NPF0001073, NPF0001074, NPF0001075, NPF0001076, NPF0001077, NPF0001078, NPF0001079, NPF0001080, NPF0001081, NPF0001083, NPF0001089, NPF0001090, NPF0001096, NPF0001099, NPF0001100, NPF0001105, NPF0001113, NPF0001114, NPF0001127, NPF0001131, NPF0001134, NPF0001148, NPF0001149, NPF0001150, NPF0001151, NPF0001156, NPF0001175, NPF0001178, NPF0001179, NPF0001180, NPF0001181, NPF0001182, NPF0001183, NPF0001184, NPF0001185, NPF0001187, NPF0001189, NPF0001190, NPF0001195, NPF0001205, NPF0001212, NPF0001240, NPF0001260, NPF0001264, NPF0001270, NPF0001273, NPF0001275, NPF0001277, NPF0001283, NPF0001289, NPF0001293, NPF0001294, NPF0001299, NPF0001316, NPF0001321, NPF0001327, NPF0001334, NPF0001339, NPF0001341, NPF0001342, NPF0001347, NPF0001359, NPF0001360, NPF0001366, NPF0001368, NPF0001370, NPF0001374, NPF0001378, NPF0001385, NPF0001393, NPF0001397, NPF0001398, NPF0001406, NPF0001407, NPF0001412, NPF0001413, NPF0001422, NPF0001423, NPF0001424, NPF0001426, NPF0001428, NPF0001429, NPF0001430, NPF0001431, NPF0001432, NPF0001433, NPF0001434, NPF0001436, NPF0001437, NPF0001445, NPF0001451, NPF0001452, NPF0001454, NPF0001455, NPF0001460, NPF0001461, NPF0001463, NPF0001464, NPF0001466, NPF0001467, NPF0001481, NPF0001484, NPF0001496, NPF0001499, NPF0001500, NPF0001503, NPF0001504, NPF0001508, NPF0001510, NPF0001513, NPF0001514, NPF0001520, NPF0001521, NPF0001522, NPF0001523, NPF0001526, NPF0001527, NPF0001528, NPF0001530, NPF0001532, NPF0001535, NPF0001536, NPF0001539, NPF0001540, NPF0001543, NPF0001550, NPF0001551, NPF0001556, NPF0001560, NPF0001562, NPF0001563, NPF0001570, NPF0001574, NPF0001576, NPF0001577, NPF0001578, NPF0001579, NPF0001585, NPF0001588, NPF0001604, NPF0001608, NPF0001621, NPF0001625, NPF0001626, NPF0001627, NPF0001628, NPF0001629, NPF0001633, NPF0001635, NPF0001636, NPF0001638, NPF0001645, NPF0001649, NPF0001650, NPF0001652, NPF0001653, NPF0001654, NPF0001656, NPF0001657, NPF0001668, NPF0001671, NPF0001672, NPF0001673, NPF0001681, NPF0001684, NPF0001690, NPF0001691, NPF0001692, NPF0001694, NPF0001698, NPF0001700, NPF0001703, NPF0001706, NPF0001707, NPF0001710, NPF0001714, NPF0001715, NPF0001718, NPF0001735, NPF0001741, NPF0001745, NPF0001747, NPF0001749, NPF0001750, NPF0001754, NPF0001755, NPF0001762, NPF0001763, NPF0001766, NPF0001767, NPF0001769, NPF0001775, NPF0001786, NPF0001789, NPF0001800, NPF0001803, NPF0001826, NPF0001837, NPF0001842, NPF0001843, NPF0001847, NPF0001857, NPF0001859, NPF0001876, NPF0001877, NPF0001880, NPF0001884, NPF0001886, NPF0001889, NPF0001892, NPF0001895, NPF0001906, NPF0001917, NPF0001929, NPF0001932, NPF0001934, NPF0001936, NPF0001937, NPF0001939, NPF0001940, NPF0001941, NPF0001942, NPF0001943, NPF0001946, NPF0001948, NPF0001949, NPF0001950, NPF0001951, NPF0001952, NPF0001954, NPF0001956, NPF0001957, NPF0001959, NPF0001960, NPF0001962, NPF0001970, NPF0001974, NPF0001976, NPF0001978, NPF0001981, NPF0001982, NPF0001985, NPF0001987, NPF0001988, NPF0001996, NPF0001997, NPF0001998, NPF0001999, NPF0002000, NPF0002004, NPF0002006, NPF0002008, NPF0002010, NPF0002011, NPF0002014, NPF0002015, NPF0002019, NPF0002022, NPF0002026, NPF0002034, NPF0002038, NPF0002044, NPF0002046, NPF0002049, NPF0002051, NPF0002054, NPF0002062, NPF0002071, NPF0002074, NPF0002096, NPF0002097, NPF0002098, NPF0002099, NPF0002100, NPF0002101, NPF0002106, NPF0002109, NPF0002110, NPF0002111, NPF0002113, NPF0002114, NPF0002124, NPF0002125, NPF0002131, NPF0002132, NPF0002138, NPF0002140, NPF0002142, NPF0002146, NPF0002150, NPF0002152, NPF0002154, NPF0002155, NPF0002156, NPF0002158, NPF0002163, NPF0002165, NPF0002166, NPF0002169, NPF0002172, NPF0002173, NPF0002178, NPF0002182, NPF0002183, NPF0002186, NPF0002187, NPF0002194, NPF0002196, NPF0002210, NPF0002219, NPF0002224, NPF0002230, NPF0002236, NPF0002238, NPF0002250, NPF0002256, NPF0002266, NPF0002271, NPF0002286, NPF0002288, NPF0002300, NPF0002314, NPF0002317, NPF0002327, NPF0002328, NPF0002333, NPF0002346, NPF0002348, NPF0002351, NPF0002352, NPF0002355, NPF0002361, NPF0002364, NPF0002378, NPF0002380, NPF0002381, NPF0002384, NPF0002399, NPF0002405, NPF0002406, NPF0002408, NPF0002411, NPF0002414, NPF0002415, NPF0002422, NPF0002423, NPF0002425, NPF0002432, NPF0002456, NPF0002459, NPF0002462, NPF0002463, NPF0002471, NPF0002484, NPF0002485, NPF0002486, NPF0002490, NPF0002497, NPF0002502, NPF0002506, NPF0002509, NPF0002548, NPF0002572, NPF0002573, NPF0002577, NPF0002581, NPF0002582, NPF0002584, NPF0002586, NPF0002610, NPF0002612, NPF0002619, NPF0002621, NPF0002623, NPF0002624, NPF0002626, NPF0002632, NPF0002641, NPF0002642, NPF0002647, NPF0002649, NPF0002655, NPF0002658, NPF0002660, NPF0002674, NPF0002682, NPF0002685, NPF0002686, NPF0002691, NPF0002694, NPF0002721, NPF0002741, NPF0002753, NPF0002756, NPF0002759, NPF0002760, NPF0002761, NPF0002762, NPF0002764, NPF0002765, NPF0002766, NPF0002767, NPF0002768, NPF0002770, NPF0002796, NPF0002797, NPF0002800, NPF0002803, NPF0002816, NPF0002831, NPF0002834, NPF0002836, NPF0002839, NPF0002840, NPF0002843, NPF0002844, NPF0002848, NPF0002849, NPF0002851, NPF0002852, NPF0002853, NPF0002854, NPF0002856, NPF0002858, NPF0002859, NPF0002864, NPF0002866, NPF0002868, NPF0002869, NPF0002871, NPF0002874, NPF0002875, NPF0002877, NPF0002878, NPF0002879, NPF0002881, NPF0002882, NPF0002883, NPF0002884, NPF0002885, NPF0002886, NPF0002887, NPF0002889, NPF0002895, NPF0002897, NPF0002911, NPF0002912, NPF0002913, NPF0002915, NPF0002916, NPF0002917, NPF0002918, NPF0002919, NPF0002922, NPF0002924, NPF0002927, NPF0002928, NPF0002929, NPF0002932, NPF0002933, NPF0002936, NPF0002938, NPF0002944, NPF0002952, NPF0002953, NPF0002954, NPF0002955, NPF0002958, NPF0002959, NPF0002961, NPF0002962, NPF0002964, NPF0002965, NPF0002966, NPF0002968, NPF0002969, NPF0002970, NPF0002971, NPF0002972, NPF0002973, NPF0002974, NPF0002975, NPF0002977, NPF0002978, NPF0002979, NPF0002984, NPF0002988, NPF0002989, NPF0002993, NPF0002994, NPF0002995, NPF0002996, NPF0002998, NPF0003011, NPF0003012, NPF0003016, NPF0003020, NPF0003021, NPF0003022, NPF0003023, NPF0003024, NPF0003025, NPF0003026, NPF0003027, NPF0003028, NPF0003029, NPF0003031, NPF0003032, NPF0003033, NPF0003034, NPF0003035, NPF0003036, NPF0003038, NPF0003039, NPF0003040, NPF0003045, NPF0003049, NPF0003056\n2) TH90QFA, UDI-Device Identifier (GTIN/UPN) 00763000582487, Serial Numbers: NPF0000658, NPF0000662, NPF0000673, NPF0000678 \n3) TH90PFA, UDI-Device Identifier (GTIN/UPN) 00763000433871, Serial Numbers: NPT0001313, NPT0051480, NPT0021804, NPT0051392, NPT0051144, NPT0001294, NPT0049798, NPT0053021, NPT0050685, NPT0001633, NPT0021799, NPT0051778, NPT0050614, NPT0001690\n4) TH90GFA, UDI-Device Identifier (GTIN/UPN) 00763000187231, Serial Numbers: NPO0014927, NPO0011973, NPO0012969, NPO0041785, NPO0013871, NPO0041444, NPO0011977, NPO0012971, NPO0012000, NPO0013811, NPO0011986, NPO0012125, NPO0011971, NPO0008660, NPO0011724, NPO0011728, NPO0011734, NPO0012060, NPO0012531, NPO0013146, NPO0013205, NPO0013212, NPO0013226, NPO0014549, NPO0042926, NPO0043071, NPO0043184, NPO0043546, NPO0012112, NPO0012804, NPO0011909, NPO0013222\n5) TH90G01, UDI-Device Identifier (GTIN/UPN) 00763000058005, Serial Numbers: NPO0042790, NPO0015230, NPO0053525\n\nb) Model Number A51300, UDI-Device Identifier (GTIN/UPN) 00763000517182\nc) Model Number A52300, UDI-Device Identifier (GTIN/UPN) 00763000517199", "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": "Katie Genereux\n763-514-0162", "reason_for_recall": "There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a \" Data Lost\" notification being displayed.", "root_cause_description": "Software Design Change", "action": "Medtronic distributed a correction notice to impacted U.S. implanting physicians, who had implanted patients with the Model 97800 InterStim X system prior to the release of the software update or purchased the TH90Q kit (in addition to notifying, Medtronic Sales Representatives and Medtronic Patient & Technical Services) on 28-Feb-2022.\n\nMedtronic distributed a correction notice to impacted U.S. hospital accounts, who have purchased the TH90Q kit containing the affected HH90 handset prior to the software updated release, on 04-Mar-2022, notifying consignees of this issue and the software update availability. Medtronic will also notify those consignees with the TH90PFA and TH90GFA kits where the affected software was installed.", "product_quantity": "1005 units", "distribution_pattern": "US Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY, AR, MO, MN, OH, CO, KS, MS, SC, LA, WA, PA, IN, SD, MI, WV, AL, GA, TN, VA, IA.", "openfda": { "pma_number": [ "P170001", "P970004", "P240031", "P180046" ], "registration_number": [ "3004209178", "2182207", "3021836309", "3018094310", "2135338", "1319639", "3003120897", "3005210579", "3003477135", "3015151147", "3014845032", "3002968685", "2124215", "3010291427", "2649622", "3019807891", "2011171", "3009380063", "3010972758", "3009183442", "2183744", "3004593495" ], "fei_number": [ "2182207", "3004369318", "3005700659", "1000138054", "3021836309", "3018094310", "3003120897", "3005210579", "3003477135", "3015151147", "3014845032", "3002968685", "2124215", "3010291427", "2649622", "3019807891", "2011171", "3009380063", "3010972758", "3009183442", "2183744", "3004593495" ], "device_name": "Stimulator, Electrical, Implantable, For Incontinence", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5270", "device_class": "3" } } ] }