Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
- Company
- Medtronic Neuromodulation
- Recall Initiated
- December 3, 2022
- Posted
- January 6, 2023
- Recall Number
- Z-0912-2023
- Quantity
- 362 units
- Firm Location
- Minneapolis, MN
Reason for Recall
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Distribution
Worldwide distribution.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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."