Medtronic Vanta/Seqenita LT Neurostimulation Programmer Software Anomalies Recalled
Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.
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 medical device programmer application. Software anomalies may interfere with proper operation of neurostimulation systems, creating a risk of harm to patient care. No reported injuries or illnesses are mentioned in the source.
Plain-English summary
Medtronic Neuromodulation is recalling the Vanta/Seqenita LT Clinician Programmer Application (Model CT900E), a software application used to program neurostimulation systems for pain management. The recall affects 22 units that were distributed worldwide.
The product has been recalled due to software anomalies that generate error messages including 'Too Many Device Found,' 'Unexpected Device Error Code 1502,' and 'System Update Needed, Service Code 303.' These error messages may interfere with normal operation of the clinician programmer.
Affected lot numbers are: NPL3022869, NPL3022873, NPL3022049, NPL3022050, NPL3022795, NPL3022817, NPL3022190, NPL3022191, NPL3022052, NPL3022187, NPL3022193, NPL3022194, NPL3022195, NPL3022212, NPL3022213, NPL3022289, NPL3021964, NPL3022043, NPL3022044, NPL3022034, NPL3021984, NPL3021990 (GTIN 00763000447090).
Clinicians and healthcare facilities using the affected units should contact Medtronic Neuromodulation for instructions on remediation or device replacement.
The recalled product
- Product
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 22
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 00763000447090: Serial/Lot Numbers: NPL3022869
- NPL3022873
- NPL3022049
- NPL3022050
- NPL3022795
- NPL3022817
- NPL3022190
- NPL3022191
- NPL3022052
- NPL3022187
- NPL3022193
- NPL3022194
- NPL3022195
- NPL3022212
- NPL3022213
- NPL3022289
- NPL3021964
- NPL3022043
- NPL3022044
- NPL3022034
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.
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