Medtronic Neurostimulation Programmer Software Errors Affect 18 Devices
Medtronic is recalling 18 units of its Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that may prevent proper operation.
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: This is a risk-of-harm medical device (neurostimulation system for pain therapy) with no reported injuries or deaths. While the FDA Class II classification indicates potential patient safety risk from the software anomalies, the absence of reported adverse events places this at the 'High' severity level per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Neuromodulation is recalling 18 units of the Vanta/Seqenita LT Clinician Programmer Application, software used to control and program Vanta/Seqenita LT neurostimulation systems for pain therapy. The recall is due to software anomalies that produce three error messages: 'Too Many Device Found,' 'Unexpected Device Error Code 1502,' and 'System Update Needed, Service Code 303.'
The affected units are distributed worldwide. The product is Model Number CT900C. The specific lot and serial numbers included in this recall are: NPL1000794, NPL1002295, NPL1002284, NPL1002272, NPL1001670, NPL1001615, NPL1001596, NPL1001588, NPL1001591, NPL1001592, NPL1001583, NPL1001579, NPL1001558, NPL1000777, NPL1000774, NPL1000776, NPL1000453, and NPL1000429.
The FDA classified this as a Class II recall.
The recalled product
- Product
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- software-anomaly
- device-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 (18)
- GTIN 00643169890961: Lot/Serial Numbers: NPL1000794
- NPL1002295
- NPL1002284
- NPL1002272
- NPL1001670
- NPL1001615
- NPL1001596
- NPL1001588
- NPL1001591
- NPL1001592
- NPL1001583
- NPL1001579
- NPL1001558
- NPL1000777
- NPL1000774
- NPL1000776
- NPL1000453
- NPL1000429
Distribution
Distribution scope not specified by the agency.
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