Class 2 Device Recall Vanta/Seqenita LT Clinician Programmer Application

• Date Initiated by Firm: December 03, 2022
• Date Posted: January 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0911-2023
• Recall Event ID: 91296
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
• Code Information: 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
• FEI Number: 2182207
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Michelle Claypool; 763-526-9452
• Manufacturer Reason for Recall: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
• FDA Determined 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 in Commerce: 440 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.