Fusion™ ENT Image Guidance System 9733560 (UDI 00763000235079)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000235079), received between Mar 13, 2019 and Jun 27, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT BEFORE A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE, THE PATIENT DATA WAS NOT BEING READ WHEN A CD WAS INSERTED. RESTARTING THE SYSTEM MAY OCCASIONALLY RESTORE FUNCTIONALITY. ADDITIONALLY, THE SYSTEM SOMETIMES FROZE DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346242 ↗
• MalfunctionJan 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING THE NAVIGATION SYSTEM. IT WAS REPORTED THAT SOME KOREAN DOMESTIC CONE BEAM CT (POINTNIX, HDX) ARE NOT COMPATIBLE WITH MEDTRONIC NAVIGATION SOMEHOW, ESPECIALLY FUSION AND FUSION COMPACT, SO THAT DEMONSTRATION WAS NOT ABLE TO PROCEED. THE SYSTEM SHOWED 'NO IMAGE LOADED'. EVEN THOUGH THE MANUFACTURER REPRESENTATIVE (REP) CHECKED IT CONTAINS ONE X-RAY IMAGE, THE REP WAS NOT ABLE TO FIND THE MAIN REASON WHY IT DOES NOT LOAD IN THE OLD SYSTEM. THE ISSUE HAS NOT BEEN RESOLVED YET. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED NO FURTHER ACTIONS WOULD BE TAKEN. IT WAS CONFIRMED THE SITE THAT THE NAVIGATION SYSTEM IN QUESTION WAS NOT COMPATIBLE BECAUSE OF THE PROGRAM SETTING (MEDIA IO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254157 ↗
• MalfunctionJun 30, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE STATING THAT YES A PATIENT WAS PRESENT AT THE TIME OF THE EVENT. IT HAPPENED REGULARLY AND CONSISTENTLY DURING THE CASE. THERE HAVE BEEN MULTIPLE PATIENTS THIS HAS OCCURRED WITH.

  Patient problems: No Patient Involvement

  MAUDE report 10213023 ↗
• MalfunctionMay 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT WHILE USING THE STRAIGHT SUCTION THE TIP WAS WORN. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8623986 ↗
• MalfunctionMar 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THERE WAS TRACKING ISSUE WITH ONE OF THE INSTRUMENTS. SO THE SITE USED A DIFFERENT AND NO ISSUE WERE FOUND WITH THE USE OF ANOTHER TRACKER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8417551 ↗

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-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1588-2014 · Apr 24, 2014 · Terminated
  MOUSE 9732721 STERILE O-ARM 10PK
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• Z-1585-2014 · Apr 24, 2014 · Terminated
  INST 9731132 KIT CR REF FRAME DRIVER 5PK
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

…and 13 more.