N/A 9733533 (UDI 00613994353450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994353450), received between Dec 15, 2016 and Jan 21, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE TRACKER HAD AN UNRECOGNIZED EVENT. IT WAS UNKNOWN IF THERE WAS AN INACCURACY IN THE NAVIGATION. THE ISSUE WAS RESOLVED WITH ANOTHER TRACKER. THEY COMPLETED THE PROCEDURE WITH THE CONTINUED USE OF THE NAVIGATION SYSTEM. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. (B)(6) 2026 (B)(6) (REP, FOR): IT WAS CONFIRMED UNKNOWN IF THERE WAS AN INACCURACY, OR IF IT WAS A TRACKING ISSUE OR VERIFICATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134080 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TRACKER CLEARLY INDICATED A POSITION THAT WAS MISALIGNED. IT WAS CHANGED TO A DIFFERENT TRACKER AND PROGRESSED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617782 ↗
• MalfunctionNov 22, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE INSTRUMENT TRACKER STOPPED WORKING MID-PROCEDURE FOR ALL INSTRUMENTS. THE SITE OPENED A NEW ONE AND THE ISSUE WAS RESOLVED. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE BEING PERFORMED WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS.) THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIVE TO TEN MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759663 ↗
• MalfunctionNov 2, 2023Mechanical Problem; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Mechanical Problem; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE WAS ATTEMPTING TO VERIFY THE INSTRUMENT TRACKER ON THE PATIENT'S FOREHEAD, BUT THE TRACKER WAS NOT FUNCTIONING CORRECTLY AND THE SITE WAS UNABLE TO REGISTER STRAIGHT SUCTION. THE GEOMETRY ERROR WAS 1.5+, AND THE DISTANCE TO DIVOT INACCURACY WAS 2MM+. THE SITE OPENED A NEW INSTRUMENT TRACKER AND IT WORKED FINE. IT WAS NOTED THAT THIS ISSUE WAS RELATED TO SOFTWARE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE ISSUE WAS WITH THE INSTRUMENT AND NOT THE SOFTWARE. REGISTRATION WAS ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056833 ↗
• MalfunctionNov 18, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS.) IT WAS REPORTED THAT NAVIGATION WORKED WELL AT THE START OF THE CASE. TOWARDS THE END OF THE CASE, THE SURGEON TRIED TO SWITCH INSTRUMENTS. THE INSTRUMENT VERIFIED WITH AUDIBLE CONFIRMATION AS WELL AS A "VERIFICATION SUCCESSFUL" AT THE BOTTOM LEFT, AND THE INSTRUMENTS SHOWING AT THE BOTTOM RIGHT. AFTER ABOUT TEN SECONDS, THE BOTTOM LEFT WOULD SWITCH TO THE WARNING, "INSTRUMENT NOT VERIFIED," AND THE CROSSHAIRS WOULD REMAIN RED DESPITE THE INSTRUMENT BEING IN THE FIELD. THE MANUFACTURER REPRESENTATIVE (REP) CHANGED THE PORTS OF BOTH THE INSTRUMENT AND PATIENT TRACKERS, THE EMITTER WAS TOGGLED OFF AND ON, NAVIGATION WAS EXITED AND RE-ENTERED, AND THE ELECTROMAGNETIC (EM) BREAKOUT BOX AND EMITTER WERE UNPLUGGED AND PLUGGED BACK IN WITH NO SUCCESS. THE SURGEON TRIED MULTIPLE DIFFERENT INSTRUMENTS, AND ALL WOULD VERIFY THEN STOP TRACKING. THERE WERE NO ISSUES WITH NAVIGATION IN OTHER CASES. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822738 ↗
• MalfunctionJun 24, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SITE HAD ISSUES WITH AN INSTRUMENT TRACKER. IT WAS REPORTED THAT DURING PATIENT REGISTRATION, THE TRACKER SIGNAL WAS LOST ON THE EMITTER. HOWEVER, REGISTRATION WAS COMPLETED WITHOUT ISSUE. IT WAS REPORTED THAT THE TRACKER COULD NOT BE RECOGNIZED WHEN THE SURGEON ATTEMPTED TO NAVIGATE A SUCTION. IT WAS REPORTED THAT THE SURGERY WAS PERFORMED WITH A NAVIGATION BLADE THAT DID NOT HAVE ISSUES. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. AFTER THE PROCEDURE, TROUBLESHOOTING IDENTIFIED THAT THE INSTRUMENT TRACKER CAUSED THE ISSUE AS IT DID NOT APPEAR CORRECTLY IN THE EMITTER FIELD OF VIEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10190717 ↗
• MalfunctionDec 15, 2016Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, THEIR EM TRACKER EXPERIENCED A RECOGNITION FAILURE. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO DISCONTINUE THE USE OF THE NAVIGATION SYSTEM TO CONTINUE THE PROCEDURE TO COMPLETION. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6177416 ↗

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-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-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-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK

…and 13 more.