Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall
Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device (neurostimulation system for pain therapy). While no injuries or hospitalizations have been reported, software anomalies in a clinician programmer could affect device operation and patient safety, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Neuromodulation is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application (Model CT900B), a software application used to program neurostimulation systems for pain therapy. The affected devices are identified by GTIN 00643169890947 and specific lot/serial numbers.
The recall is due to software anomalies in the Clinician Programmer Application that may cause three distinct error messages to display: "Too Many Device Found," "Unexpected Device Error Code 1502," or "System Update Needed, Service Code 303." These errors could impair the programmer's ability to function properly.
The affected units have been distributed worldwide. Healthcare providers and clinicians using the affected programmer should contact Medtronic Neuromodulation for instructions regarding corrected software or device replacement.
The recalled product
- Product
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 362
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · software malfunction
See all →- HighPhilips PIC iX Essentials Patient Information System Software Recall
FDA (Devices) · 2026-09-23
- HighPhilips Patient Information Center iX Software Malfunction Recall
FDA (Devices) · 2026-09-23
- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
- HighSiemens Interventional Fluoroscopic X-Ray System Software Communication Failure
FDA (Devices) · 2025-07-09
Similar recalls
- HighVanta Clinician Programmer Application error prevents programming of implanted neurostimulators
FDA (Devices) · 2022-08-31
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighVanta INS Neurostimulator May Fail to Communicate with Programmer Systems
FDA (Devices) · 2022-06-01
- ModerateMedtronic Restore Clinician Programmer software recalled for compatibility issue
FDA (Devices) · 2023-10-11
- ModerateMedtronic Intellis Spinal Cord Stimulator Software Recall
FDA (Devices) · 2021-01-20
- ModerateVanta Clinician Programmer Software Cannot Connect with Multiple Implants
FDA (Devices) · 2022-08-31