eTRAX™ Needle Sensor 667-158Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Mar 2, 2026Open, Classified

   There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

   Z-1737-2026 · Root cause: Software change control · 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-1736-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
• Z-1732-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
• Z-1738-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
• Z-1735-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
• Z-1734-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
• Z-1733-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
• Z-1731-2026 · Mar 2, 2026 · Open, Classified
  eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
• Z-0396-2022 · Oct 8, 2021 · Terminated
  VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
• Z-0397-2022 · Oct 8, 2021 · Terminated
  VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
• Z-0398-2022 · Oct 8, 2021 · Terminated
  VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
• Z-0395-2022 · Oct 8, 2021 · Terminated
  VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
• 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
• Z-1955-2012 · May 7, 2012 · Terminated
  CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is
• 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-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

…and 1 more.