N/A 9733447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994378491), received between Oct 7, 2021 and Oct 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

28 other recalls cover devices cleared under the same FDA submission (K001284); 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.

• MalfunctionOct 7, 2021Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THAT THE STRAIGHT PROBE WAS BENT. IT WAS DISCOVERED WITHOUT A PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001284. One submission often covers many models, so check the product and lot details in each record.

• Z-2317-2016 · Jul 18, 2016 · Terminated
  Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Syste
• Z-2319-2016 · Jul 18, 2016 · Terminated
  MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Sys
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1585-2014 · Apr 24, 2014 · Terminated
  INST 9731132 KIT CR REF FRAME DRIVER 5PK
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
• Z-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE

…and 13 more.