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MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL… recallZ-0998-2022 · Medtronic Neuromodulation · initiated Feb 28, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Design Change

What the company is doing

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. Medtronic 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.

Recall details

Recall number
Z-0998-2022
Status
Terminated
Initiated by the company
Feb 28, 2022
Posted by the FDA
Apr 22, 2022
Recalling firm
Medtronic Neuromodulation
Quantity
1005 units
Product code
EZW
FDA submissions
P080025, P970004
Distribution
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.

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 information (models, lots, serial numbers)

Show the full code information (13k characters)

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

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

53 devices cleared under P080025, P970004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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