N/A 9733533XOMRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994380012), received between Feb 1, 2019 and Jun 27, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; 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 THERE WAS AN INACCURACY PRIOR TO NAVIGATION. THE NAVIGATION INSTRUMENT DID NOT APPEAR AFTER CONNECTION. A NEW TRACKER WAS USED TO PROCEED WITH THE CASE. THIS RESULTED IN A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345822 ↗
• MalfunctionNov 8, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT TRACK. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. THIS RESULTED IN A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639753 ↗
• MalfunctionNov 7, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE SETTING UP FOR SURGERY, THE SITE PLUGGED THE INSTRUMENT TRACKER INTO THE EMITTER (EM) INTERFACE AND WERE UNABLE TO TRACK. THEY TRIED PLUGGING THE TRACKER INTO DIFFERENT PORTS ON THE EM INTERFACE AND REBOOTED THE SYSTEM WITH NO CHANGE. THEY OPENED UP ANOTHER INSTRUMENT TRACKER AND PLUGGED INTO THE SAME PORT, ABLE TO TRACK/VERIFY AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629139 ↗
• MalfunctionDec 3, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS.) IT WAS REPORTED THAT THE INSTRUMENT TRACKER COULD NOT BE RECOGNIZED IN ANY OF THE PORTS. A NEW TRACKER WAS OPENED, AND THE SURGERY CONTINUED. THIS ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923448 ↗
• MalfunctionSep 14, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE'S FUSION SYSTEM HAD AN INSTRUMENT TRACKER STOP TRACKING IN THE MIDDLE OF A CASE ON. THERE WAS A PATIENT PRESENT AND A ONE-MINUTE DELAY. THE INSTRUMENT WAS REPLACED. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10529088 ↗
• MalfunctionJul 16, 2019Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SITE HAD ISSUES DURING PATIENT REGISTRATION. IT WAS REPORTED THAT TWO INSTRUMENT TRACKERS AND THE MICRODEBRIDER WERE PLUGGED INTO THE SYSTEM AND WHEN ATTEMPTING TO INSERT THE PROBE INTO THE DIVOT OF THE PATIENT REFERENCE FRAME, THE NAVIGATION SYSTEM ONLY RECOGNIZED THE MICRODEBRIDER. THE MICRODEBRIDER WAS THEN UNPLUGGED AND THE NAVIGATION SYSTEM WOULD NOT RECOGNIZE THE TWO TRACKERS. THE APPLICATION SOFTWARE WAS EXITED, ANOTHER TOOL WAS TESTED AND THE NAVIGATION SYSTEM FUNCTIONED AS DESIGNED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIVE MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795371 ↗
• MalfunctionMar 11, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE NAVIGATION SYSTEM WAS RESTARTED WITHOUT RESOLUTION DURING THE PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF ABOUT TEN MINUTES DUE TO THE REPORTED ISSUE. IT WAS REPORTED THAT THE ISSUE OCCURRED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), S, T AND A POLYP REMOVAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408529 ↗
• MalfunctionFeb 1, 2019Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE PATIENT TRACKER WAS BAD AT THE INSTALL AND WOULD NOT TRACK. THE SITE OPENED ANOTHER ONE AND IT WORKED AS EXPECTED. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296894 ↗

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-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK
• Z-1583-2014 · Apr 24, 2014 · Terminated
  DRAPE 9732722 TUBE STERILE O-ARM 20PK
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1585-2014 · Apr 24, 2014 · Terminated
  INST 9731132 KIT CR REF FRAME DRIVER 5PK
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1581-2014 · Apr 24, 2014 · Terminated
  DISP 9730950 STRL SPHERE, 1 PK INSERT
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR

…and 13 more.