Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Mo...
FDA Recall #Z-0912-2023 — Class II — December 3, 2022
Product Description
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Reason for Recall
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Recalling Firm
Medtronic Neuromodulation — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
362 units
Distribution
Worldwide distribution.
Code Information
GTIN 00643169890947: Serial/Lot Numbers: NPL1001759, NPL1002443, NPL1000118, NPL1001372, NPL1001373, NPL1000135, NPL1000138, NPL1000062, NPL1000060, NPL1001408, NPL1001241, NPL1002741, NPL1002730, NPL1000183, NPL1001773, NPL1001678, NPL1000332, NPL1000065, NPL1000073, NPL1000281, NPL1000301, NPL1001551, NPL1001687, NPL1001711, NPL1001712, NPL1001717, NPL1001724, NPL1001728, NPL1001740, NPL1001754, NPL1001769, NPL1001793, NPL1001812, NPL1001813, NPL1001816, NPL1001823, NPL1001885, NPL1001887, NPL1001995, NPL1001996, NPL1002426, NPL1000067, NPL1000069, NPL1000074, NPL1000296, NPL1000303, NPL1000361, NPL1000362, NPL1000483, NPL1000485, NPL1000486, NPL1000487, NPL1001520, NPL1001549, NPL1001705, NPL1001716, NPL1001723, NPL1001727, NPL1001746, NPL1001748, NPL1001756, NPL1001763, NPL1001789, NPL1001802, NPL1001811, NPL1001817, NPL1001821, NPL1001824, NPL1001879, NPL1001881, NPL1001886, NPL1001888, NPL1001963, NPL1002422, NPL1002428, NPL1001246, NPL1000046, NPL1000049, NPL1000053, NPL1000151, NPL1002487, NPL1001689, NPL1002674, NPL1000510, NPL1002639, NPL1002640, NPL1002787, NPL1002800, NPL1002461, NPL1002467, NPL1002468, NPL1000577, NPL1000561, NPL1001742, NPL1001761, NPL1002733, NPL1001464, NPL1002227, NPL1002234, NPL1002222, NPL1001523, NPL1002482, NPL1002152, NPL1002691, NPL1001504, NPL1001506, NPL1001936, NPL1001937, NPL1002470, NPL1002471, NPL1002690, NPL1000584, NPL1002665, NPL1002706, NPL1001550, NPL1002780, NPL1001755, NPL1000640, NPL1000652, NPL1000653, NPL1001439, NPL1001440, NPL1001889, NPL1002064, NPL1002065, NPL1002066, NPL1002067, NPL1002068, NPL1002548, NPL1002650, NPL1002698, NPL1001957, NPL1001766, NPL1002598, NPL1000290, NPL1000291, NPL1001376, NPL1001815, NPL1001825, NPL1001545, NPL1002483, NPL1002490, NPL1002491, NPL1002493, NPL1001239, NPL1002540, NPL1001750, NPL1002484, NPL1001770, NPL1001395, NPL1001396, NPL1002539, NPL1000518, NPL1002624, NPL1001749, NPL1001709, NPL1002735, NPL1001445, NPL1001757, NPL1002626, NPL1002506, NPL1002678, NPL1001249, NPL1002088, NPL1002662, NPL1002719, NPL1002699, NPL1002703, NPL1002633, NPL1001537, NPL1001543, NPL1001547, NPL1002505, NPL1001530, NPL1001536, NPL1001546, NPL1001548, NPL1001706, NPL1002672, NPL1002673, NPL1000634, NPL1002666, NPL1002618, NPL1002647, NPL1001739, NPL1002419, NPL1001212, NPL1002570, NPL1001751, NPL1002568, NPL1002572, NPL1000094, NPL1002556, NPL1000380, NPL1002555, NPL1000504, NPL1001744, NPL1002592, NPL1000575, NPL1002499, NPL1002500, NPL1001332, NPL1001526, NPL1001535, NPL1001843, NPL1002440, NPL1002445, NPL1002526, NPL1002527, NPL1002435, NPL1001695, NPL1001765, NPL1002092, NPL1002410, NPL1002382, NPL1002380, NPL1002370, NPL1002345, NPL1002346, NPL1002347, NPL1002361, NPL1002340, NPL1001745, NPL1002090, NPL1002330, NPL1002367, NPL1002368, NPL1002369, NPL1000381, NPL1001708, NPL1002325, NPL1001694, NPL1001707, NPL1001764, NPL1002243, NPL1001454, NPL1001455, NPL1001457, NPL1002252, NPL1001458, NPL1002213, NPL1001446, NPL1001842, NPL1001847, NPL1000558, NPL1002089, NPL1002091, NPL1001792, NPL1001421, NPL1001422, NPL1001423, NPL1001508, NPL1000369, NPL1001741, NPL1001381, NPL1001841, NPL1001379, NPL1001380, NPL1002093, NPL1002094, NPL1002095, NPL1001743, NPL1001700, NPL1001804, NPL1001820, NPL1001347, NPL1001348, NPL1001703, NPL1001710, NPL1000055, NPL1000092, NPL1001339, NPL1001697, NPL1001313, NPL1001290, NPL1000081, NPL1001291, NPL1001699, NPL1001701, NPL1001287, NPL1001787, NPL1001794, NPL1001797, NPL1001800, NPL1001795, NPL1001272, NPL1001273, NPL1001274, NPL1000298, NPL1001777, NPL1000297, NPL1001798, NPL1001799, NPL1001801, NPL1001702, NPL1001948, NPL1000076, NPL1001767, NPL1000075, NPL1001487, NPL1001226, NPL1001512, NPL1001208, NPL1000233, NPL1000239, NPL1001875, NPL1001876, NPL1001805, NPL1001507, NPL1000258, NPL1000580, NPL1000174, NPL1000070, NPL1000071, NPL1000248, NPL1000257, NPL1001434, NPL1001435, NPL1001436, NPL1000364, NPL1000252, NPL1000231, NPL1000322, NPL1000323, NPL1000328, NPL1000331, NPL1000057, NPL1000072, NPL1000325, NPL1000326, NPL1000329, NPL1000363, NPL1000365, NPL1000295, NPL1000193, NPL1000173, NPL1000512, NPL1000528, NPL1000576, NPL1000238, NPL1000195, NPL1000324, NPL1000578, NPL1000056, NPL1000242, NPL1000334, NPL1000037, NPL1000230, NPL1000137, NPL1000185, NPL1000165, NPL1000304, NPL1000305, NPL1000175, NPL1000179, NPL1000180, NPL1000292, NPL1000368, NPL1000366, NPL1000343, NPL1000344, NPL1000320
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.