CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report

Vanta/Seqenita LT Clinician Programmer Application recalled

Medtronic Neuromodulation is recalling Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain. The recall was initiated on 3 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 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 recalled362 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0912-2023
FDA event ID: 91296
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2022
FDA classified: 6 Jan 2023
Reported: 18 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Dec 2022	Recall initiated by company
6 Jan 2023	Classified by FDA	+34 days
18 Jan 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain recalled?

Yes. Medtronic Neuromodulation recalled Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain on 3 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-0912-2023.

Why was it recalled?

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Which lots are affected?

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

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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