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VirtuTRAX Instrument Navigator 5350925Recalls & reported problems

Civco Medical Instruments CO., Inc. · Reusable non-sterile general purpose driveBAY™, trakSTAR™, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex™ sensor covers (5) · Class 2

All models of VirtuTRAX Instrument Navigator (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

16 other recalls cover devices cleared under the same FDA submission (K092619); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Oct 8, 2021Class IITerminated

    There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

    Z-0395-2022 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092619. One submission often covers many models, so check the product and lot details in each record.

  • Z-1731-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
  • Z-1737-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
  • Z-1733-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
  • Z-1734-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
  • Z-1735-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
  • Z-1736-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
  • Z-1738-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
  • Z-1732-2026 · Mar 2, 2026 · Open, Classified
    eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
  • Z-0397-2022 · Oct 8, 2021 · Terminated
    VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
  • Z-0396-2022 · Oct 8, 2021 · Terminated
    VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
  • Z-0398-2022 · Oct 8, 2021 · Terminated
    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
  • Z-1956-2012 · May 7, 2012 · Terminated
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to
  • Z-1952-2012 · May 7, 2012 · Terminated
    CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to
  • Z-1953-2012 · May 7, 2012 · Terminated
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441
  • Z-1954-2012 · May 7, 2012 · Terminated
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1

…and 1 more.

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Sources and updates

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