Neurostimulation Clinician Programmer Software Anomalies Affecting Device Control
Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.
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 medical device recall involving software anomalies in a neurostimulation system used for patient pain therapy. No illnesses or injuries have been reported; however, software malfunctions affecting clinician control of a risk-of-harm medical device justify a High rating.
Plain-English summary
Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application, a software system for neurostimulation devices used in pain therapy (Model CT900A). These units were distributed worldwide.
The application experiences software anomalies that trigger error messages, including 'Too Many Device Found,' 'Unexpected Device Error Code 1502,' and 'System Update Needed, Service Code 303.' These errors can prevent clinicians from properly controlling and managing neurostimulation therapy.
Users with affected units should contact Medtronic Neuromodulation for a software fix or device replacement. Patients and healthcare providers can verify whether their device is included in the recall by checking the affected lot numbers against the FDA's recall notice.
The recalled product
- Product
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- software-malfunction
- communication-error
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 00643169890923: Serial/Lot Numbers: NPL0000474
- NPL0000027
- NPL0000072
- NPL0000284
- NPL0000561
- NPL0003519
- NPL0003792
- NPL0000454
- NPL0002036
- NPL0004205
- NPL0004222
- NPL0003112
- NPL0001300
- NPL0003989
- NPL0004099
- NPL0004693
- NPL0004711
- NPL0004761
- NPL0003189
- NPL0001861
Distribution
Distribution scope not specified by the agency.
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