The Recall Desk
HighFDA (Devices)·Z-0913-2023·Announced 2023-01-18

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
Category
Medical Device — Neurostimulation / Programmer
Hazard
Affected units
18

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.

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 →

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