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
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-0913-2023
- 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 CT900C
Where it was distributed
Worldwide distribution.
Questions about this recall
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 00643169890961: Lot/Serial Numbers: NPL1000794, NPL1002295, NPL1002284, NPL1002272, NPL1001670, NPL1001615, NPL1001596, NPL1001588, NPL1001591, NPL1001592, NPL1001583, NPL1001579, NPL1001558, NPL1000777, NPL1000774, NPL1000776, NPL1000453, NPL1000429,
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 91296More recalls from Medtronic Neuromodulation
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled | Medtronic Neuromodulation | Other | Nationwide |
| Device | CLASS II | Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled | Medtronic Neuromodulation | Other | Nationwide |
| Device | CLASS II | A71200 Vanta" Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Restore Clinician Programmer Application (CP App) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
| Device | CLASS II | Enhanced Verify Evaluation Handset (CFN HH90130FA) recalled | Medtronic Neuromodulation | Device Malfunction | Nationwide |
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