The Recall Desk
HighFDA (Devices)·Z-0912-2023·Announced 2023-01-18

Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall

Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.

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 an FDA Class II recall of a risk-of-harm medical device (neurostimulation system for pain therapy). While no injuries or hospitalizations have been reported, software anomalies in a clinician programmer could affect device operation and patient safety, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Neuromodulation is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application (Model CT900B), a software application used to program neurostimulation systems for pain therapy. The affected devices are identified by GTIN 00643169890947 and specific lot/serial numbers.

The recall is due to software anomalies in the Clinician Programmer Application that may cause three distinct error messages to display: "Too Many Device Found," "Unexpected Device Error Code 1502," or "System Update Needed, Service Code 303." These errors could impair the programmer's ability to function properly.

The affected units have been distributed worldwide. Healthcare providers and clinicians using the affected programmer should contact Medtronic Neuromodulation for instructions regarding corrected software or device replacement.

The recalled product

Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Neurostimulation / Programmer Application
Hazard
Affected units
362

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 00643169890947: Serial/Lot Numbers: NPL1001759
  • NPL1002443
  • NPL1000118
  • NPL1001372
  • NPL1001373
  • NPL1000135
  • NPL1000138
  • NPL1000062
  • NPL1000060
  • NPL1001408
  • NPL1001241
  • NPL1002741
  • NPL1002730
  • NPL1000183
  • NPL1001773
  • NPL1001678
  • NPL1000332
  • NPL1000065
  • NPL1000073
  • NPL1000281

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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