Medtronic Vanta Seqenita LT Neurostimulation Device Recalled for Software Anomalies
Medtronic is recalling 1,337 Vanta Seqenita LT neurostimulation programmer units worldwide due to software anomalies that generate specific error messages in the clinician application.
What this means for you
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: FDA Class II classification indicates potential for adverse health consequences. This is a neurostimulation device where software anomalies pose a risk of treatment interference; no patient injuries have been reported, placing this in the High severity category per FDA recall criteria.
Plain-English summary
Medtronic Neuromodulation is recalling the Vanta/Seqenita LT Clinician Programmer Application (Model CT900D), a software component of neurostimulation systems used for pain therapy. The recall affects 1,337 units distributed worldwide.
The recall is prompted by software anomalies in the clinician programmer application that generate specific error messages: "Too Many Device Found," "Unexpected Device Error Code 1502," and "System Update Needed, Service Code 303." These software anomalies affect the proper operation of the device's programming interface.
The FDA has classified this as a Class II recall (Z-0914-2023). Affected units are identified by specific serial and lot numbers listed in the official FDA recall notice. Healthcare providers and clinicians using these systems should verify their device identifiers and contact Medtronic Neuromodulation for guidance on appropriate remedial actions.
The recalled product
- Product
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- software-anomaly
- malfunction
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 00763000077730: Serial/Lot Numbers: NPL3007591
- NPL3013601
- NPL3001811
- NPL3006844
- NPL3002246
- NPL3011056
- NPL3014275
- NPL3000542
- NPL3015356
- NPL3006821
- NPL3006824
- NPL3013679
- NPL3008056
- NPL3015357
- NPL3015563
- NPL3014832
- NPL3014949
- NPL3015345
- NPL3001926
- NPL3015319
Distribution
Distribution scope not specified by the agency.
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