N/A 9450003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902572715), received between Feb 10, 2017 and Feb 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031003); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLLOWING A METRIX DECOMPRESSION WITH EMG MONITORING VIA NIM AND ELECTRODES, "WHEN STAFF WAS REMOVING THE NEEDLE ELECTRODES IT WAS NOTICED THAT ONE NEEDLE HAD BROKEN OFF AND WAS UNDER THE SKIN IN THE MUSCLE OF THE PATIENT, CONFIRMED W XRAY." FRAGMENT REMAINS IN THE EXTENSOR HALLUCIS LONGUS. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED STATING THAT FOR THE PROCEDURE THE ELECTRODE WAS "BENT AT A 90 DEGREE ANGLE TO INSERT AND TO REDUCE THE CHANCE OF THE PLASTIC TIP BEING PULLED OUT OF THE SKIN." WHEN THE FRAGMENT WAS DISCOVERED THE PHYSICIAN HAD PLANNED ON REMOVING IT, HOWEVER, THE PATIENT CHOSE TO LEAVE IT IN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6322011 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031003. One submission often covers many models, so check the product and lot details in each record.

• Z-0947-2009 · Nov 21, 2008 · Terminated
  VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated