Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Summary
The FDA issued a Class II for Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for by Medtronic Neuromodulation. Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303".
Details
Source
Device Recall
External ID
Z-0912-2023
Action Date
2023-01-18
Status
Ongoing
Category
device
Product Description
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
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
Quantity Affected: 362 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-03
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0912-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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