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Medtronic Neuromodulation Recall 89799

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

Medtronic Neuromodulation Recall 89799 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0998-2022
Event ID89799
Event DescriptionMEDTRONIC 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
Product TypeDevices
DistributionUS 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.
Quantity1005 units
Recall ReasonThere 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.
Device Classification20220504
Device Code Infoa) Model Numbers: 1) 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 2) TH90QFA, UDI-Device Identifier (GTIN/UPN) 00763000582487, Serial Numbers: NPF0000658, NPF0000662, NPF0000673, NPF0000678 3) TH90PFA, UDI-Device Identifier (GTIN/UPN) 00763000433871, Serial Numbers: NPT0001313, NPT0051480, NPT0021804, NPT0051392, NPT0051144, NPT0001294, NPT0049798, NPT0053021, NPT0050685, NPT0001633, NPT0021799, NPT0051778, NPT0050614, NPT0001690 4) 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 5) TH90G01, UDI-Device Identifier (GTIN/UPN) 00763000058005, Serial Numbers: NPO0042790, NPO0015230, NPO0053525 b) Model Number A51300, UDI-Device Identifier (GTIN/UPN) 00763000517182 c) Model Number A52300, UDI-Device Identifier (GTIN/UPN) 00763000517199
Center Classification Date20220422
Recall Initiation Date20220228
Recalling FirmMedtronic Neuromodulation
Initial Notification Letter
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