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FDA Medical Device Recalls (openFDA)

Medtronic Neuromodulation: Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A

Recall number
Z-0911-2023
Recalling firm
Medtronic Neuromodulation
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Status
Open, Classified
Initiated
2022-12-03
Posted
2023-01-06
Terminated
not on file
Reason
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Root cause
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: "Recommended Mitigation If 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." "Medtronic is working on a Vanta CP App software update that will resolve this issue and will communicate additional information when it becomes available."
Quantity
440 units
Distribution
Worldwide distribution.
Lot, serial or model codes
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
510(k) numbers
not on file
PMA numbers
not on file
Product code
LGW
Firm FEI
2182207
Firm city
Minneapolis
Firm state
MN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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