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MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset...

FDA Device Recall #Z-0998-2022 — Class II — February 28, 2022

Recall Summary

Recall Number Z-0998-2022
Classification Class II — Moderate risk
Date Initiated February 28, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Neuromodulation
Location Minneapolis, MN
Product Type Devices
Quantity 1005 units

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

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.

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.

Lot / Code Information

a) 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

Other Recalls from Medtronic Neuromodulation

Recall # Classification Product Date
Z-1043-2026 Class II A71200 Vanta" Clinician Programmer Application ... Dec 3, 2025
Z-0996-2026 Class II Restore Clinician Programmer Application (CP Ap... Nov 20, 2025
Z-1704-2025 Class II Enhanced Verify Evaluation Handset (CFN HH90130FA) Apr 3, 2025
Z-1543-2025 Class II Stimulation RC Clinician Programmer Application... Mar 4, 2025
Z-1506-2025 Class II A820 myPTM Software Application associated with... Jan 9, 2025

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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