Fusion™ ENT Image Guidance System 9733560XOM (UDI 00643169518452)Recalls & reported problems
Medtronic Navigation, Inc. · SYSTEM 9733560XOM FUSION EM · Class 2
All models of Fusion ENT Image Guidance System (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Fusion ENT navigation system shows scans and tracks surgical instruments during ENT surgery. Many of its 188 reports describe no-input errors at startup, instruments not tracking, scans that fail to load, and programs that freeze. Most reports say no patient was involved. There are 2 injury reports and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 188
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00643169518452), received between Oct 6, 2016 and May 13, 2025 — classified as 2 injuries, 186 malfunctions.
The most frequently reported specific device problem is “Human-Device Interface Problem” (42 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Human-Device Interface Problem42
- Imprecision25
- Communication or Transmission Problem22
- Mechanical Problem22
- Application Program Freezes or Fails to Launch19
- Display or Visual Feedback Problem14
- Device Sensing Problem11
- Output Problem10
Patient problems
- No Known Impact Or Consequence To Patient74
- No Patient Involvement65
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient13
- Headache1
Recent adverse event reports
The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN EXAM LOADING ISSUE ON THE SYSTEM. WHEN ATTEMPTING TO LOAD A PATIENT EXAM VIA CD, THE SYSTEM PROGRESSED TO 99% PROGRESS COMPLETION BEFORE STOPPING, AND AN ERROR MESSAGE INDICATED "NO SOURCE DATA." IT WAS LATER REPORTED THAT THE DISC WAS THE ROOT ISSUE. THE ISSUE WAS RESOLVED WHEN A NEW DISC WAS BURNED, ALLOWING THE EXAM TO LOAD SUCCESSFULLY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013987 ↗MalfunctionApr 1, 2025Application Program Problem; Device Sensing Problem; Application Program Problem; 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 INSTRUMENTS WERE NOT TRACKING. THE EMITTER DISPLAYED A 'LOW SIGNAL' WARNING. THE USER WAS ADVISED TO CHECK FOR POTENTIAL METAL INTERFERENCE, AND IT WAS DETERMINED THAT A MAYO STAND WAS POSITIONED NEXT TO THE EMITTER. REMOVING THE MAYO STAND IMPROVED INSTRUMENT TRACKING. DURING NAVIGATION, THE SURGEON REPORTED THAT THE STRAIGHT SUCTION INSTRUMENT WAS INTERMITTENTLY FLICKERING. THE USER REPOSITIONED THE EMITTER TO FIND THE OPTIMAL PLACEMENT FOR THIS PROCEDURE. RAISING THE EMITTER AND POSITIONING IT CLOSER TO THE PATIENT HELPED STABILIZE INSTRUMENT TRACKING. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21740271 ↗MalfunctionOct 28, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 THE FUSION WAS STATING NO SYNC. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545572 ↗MalfunctionOct 14, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 WHEN STARTING THE SYSTEM FOR A CASE, THE SITE RECEIVED "NO INPUT DETECTED.". THERE WAS TROUBLESHOOTING PRESENT. IT WAS REPORTED THAT THAT THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY WAS RESET AND THE SYSTEM BOOTED UP AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20442068 ↗MalfunctionOct 7, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE REPRESENTATIVE WENT TO THE SITE TO CHECK THE SYSTEM, IT WAS FOUND TO BE MALFUNCTIONING. UPON POWERING ON THE MACHINE, THE COMPUTER DID NOT BOOT UP PROPERLY. ERROR MESSAGE: ¿NO INPUT DETECTED¿ CMOS BATTERY WAS RESET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384468 ↗MalfunctionSep 15, 2024Communication or Transmission Problem; Communication or Transmission Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE LOADED THE PATIENT'S SCAN FROM A CD, THE 4 SCANS DID NOT COMPLETELY LOAD (MISSING SLICES, LINES THROUGH IMAGES). SITE WAS ABLE TO LOAD THE SAME IMAGES FROM THE SAME CD ON THEIR NAVIGATION SYSTEM SUCCESSFULLY AND ALL SLICES LOADED. THIS OCCURRED PREOPERATIVELY, AND THERE WAS NO SURGICAL DELAY. NAVIGATION WAS ABORTED, AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20221324 ↗MalfunctionAug 21, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE ON SITE AND TURNING ON THE SYSTEM, THE MANUFACTURER REPRESENTATIVE (REP) WAS RECEIVING A "NO INPUT DETECTED" ON THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20014019 ↗MalfunctionAug 12, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 THE SYSTEM DISPLAYED 'NO INPUT DETECTED' WHEN THE HEALTHCARE PROVIDER (HCP) TURNED THE SYSTEM ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19964359 ↗MalfunctionAug 9, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING A NO INPUT DETECTED. A MEDTRONIC REPRESENTATIVE (REP) WALKED THE SITE THROUGH RESETTING THE CMOS (COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) BATTERY. PATIENT WAS NOT IN THE ROOM. THE CHOICES WERE CANCEL THE CASE OR RESET THE CMOS BATTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19954049 ↗MalfunctionApr 12, 2024No Device Output; Device Sensing Problem; No Device Output; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS "HAVING ISSUES PASSING REGISTRATION AND VERIFYING INSTRUMENTS." THE SURGERY WAS ABORTED ALONG WITH MANUFACTURER IMAGING AND NAVIGATION. PATIENT IMPACT AND DELAY UNKNOWN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095654 ↗MalfunctionJan 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO PULL UP THE CORRECT SCREEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18436139 ↗MalfunctionNov 8, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED NO INPUT DETECTED. THE REPRESENTATIVE HIT THE CMOS REST AND IT RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093361 ↗MalfunctionSep 26, 2023Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EMITTER HAD A RED X THROUGH IT. EMITTER DETAILS REPORT: AXIEM CONTROLLER NOT CONNECTED MESSAGE APPEARED. THE SITE NOTICED THAT THE EMITTER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED, THE SITE COULD NOT HEAR THE EMITTER. THERE WAS A NUMBER ON THE AXIEM CONTROLLER THAT LOOKED TO BE A NUMBER 8. THE SYSTEM WAS RESTARTED, THE AXIEM CONTROL WAS UNPLUGGED FOR 30-60 SECONDS, AND THE AXIEM WAS PLUGGED BACK IN. AN ORANGE DOTTED LINE WAS ON THE SETUP EQUIPMENT. THE FANS RAN WHEN THE AXIEM WAS PLUGGED BACK IN, BUT THE AXIEM CONTROLLED NOT CONNECTED MESSAGE STILL APPEARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17817313 ↗MalfunctionSep 19, 2023Device Sensing Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO TRACK THE NON-INVASIVE PATIENT TRACKER. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED, UPON CHECKING THE INSTRUMENTS AT THE SITE AND NOT AT THE SITE IN THE ADMINISTRATION MENU, THE NON INVASIVE PATIENT TRACKER TOOL CARD DID NOT SHOW UP IN EITHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773085 ↗MalfunctionAug 8, 2023Imprecision; Imprecision
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT A SURGEON USING THE NAVIGATION SYSTEM EXPERIENCED AN ALLEGED INACCURACY OF "A FEW MILLIMETERS." NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479353 ↗MalfunctionApr 4, 2023Communication 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 THE CD DRIVE WAS TAKING A LONG TIME TO LOAD THE CD CONTENT, AND IT WAS NOTED THAT ALL SLICES WERE NOT LOADED. ADDITIONALLY, WHILE SETTING UP THE CASE, SYSTEM DISPLAYED "LOCALIZER NOT CONNECTED" TO ALL 4 PORTS ON THE NAVIGATION SYSTEM. IT WAS NOTED THAT ALL 4 PORTS ON THE INSTRUMENT INTERFACE LIT GREEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674986 ↗MalfunctionOct 12, 2022Device Sensing Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A PROCEDURE. IT WAS REPORTED THAT TWO SUCTIONS WERE NOT ABLE TO BE TRACKED AND IT APPEARED RED ON THE SCREEN. IT WAS SHOWING THE INSTRUMENT WASN'T CONNECTED, HOWEVER ONE SEEMED TO STAY CONNECTED BETTER THEN THE OTHER. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15587682 ↗MalfunctionAug 17, 2022Imprecision; Imprecision
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING A PROCEDURE A CT SCAN WAS USED TO REGISTER AND THE SURGEON FELT THAT THE SYSTEM WAS INACCURATE BY A FEW MM. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15241227 ↗MalfunctionJul 28, 2022Communication 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 FOR A PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE WAS ATTEMPTING TO LOAD AN EXAM FROM A CD TO THIS SYSTEM, THE FUSION DISPLAYED AN ERROR MESSAGE STATING "THE FOLLOWING EXAMS WERE NOT IMPORTED CORRECTLY". THE PROCEDURE WAS ABORTED AND RESCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15121305 ↗MalfunctionMar 11, 2022Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE EMITTER WAS RED AND WOULD NOT TRACK WHEN IN USE. USE OF IMAGING AND USE OF NAVIGATION WAS DISCONTINUED. THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR AND THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13734682 ↗MalfunctionJan 4, 2022Device Sensing Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE COULD NOT GET A REGISTRATION PROBE TO TRACK. THE SURGICAL TEAM REPORTED HAVING CONFIRMED MINIMAL TO NO METAL IN THE FIELD AND HAVING REUSED THE TRACKER. IT WAS REPORTED THAT NAVIGATION WAS ABORTED. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME AND A REPORTED DELAY OF LESS THAN ONE HOUR. THE REPRESENTATIVE CONFIRMED THE ISSUE WAS MOST LIKELY CAUSED BY THE TRACKER NOT BEING FUNCTIONAL AND CONFIRMED THE SYSTEM WAS FULLY OPERATIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13154157 ↗MalfunctionSep 13, 2021Imprecision; Imprecision
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS INACCURACY OF 5MM DURING A CASE. ALL OF THE INSTRUMENTS BEING USED DEMONSTRATED INACCURACY, THE REPRESENTATIVE MADE SURE THAT THERE WAS NO METAL INTERFERENCE, AND THERE WAS NO EVIDENCE OF THE PATIENT TRACKER BEING MOVED DURING THE CASE. THE REPRESENTATIVE WAS REQUESTING A FULL SYSTEM CHECKOUT. THE SYSTEM WAS ON AN SSA. THERE WAS NO IMPACT TO THE PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12463322 ↗MalfunctionJul 1, 2021Environmental Compatibility Problem; Application Program Freezes or Fails to Launch; Environmental Compatibility Problem; Application Program Freezes or Fails to Launch
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM, BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SYSTEM WOULD NO LONGER POWER ON. THE SITE WAS USING THE SYSTEM AND THEN IT SHUT DOWN. THEY WERE THEN UNABLE TO GET THE SYSTEM TO POWER BACK ON. THE GREEN POWER BUTTON WAS NOT ILLUMINATING. THERE WAS NO VISIBLE DAMAGE ON THE CABLE AND THEY ATTEMPTED TO USE A DIFFERENT POWER OUTLET. THE NURSE ALSO CONFIRMED THAT THE POWER CABLE WAS NOT PULLED TOO TIGHT ON THE LOWER PANEL. USE OF NAVIGATION WAS ABORTED. THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR AND THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12101199 ↗MalfunctionJun 29, 2021Display or Visual Feedback Problem; Environmental Compatibility Problem; Display or Visual Feedback Problem; Environmental Compatibility Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM APPEARED TO SHUTDOWN AND THEN GO INTO "NO INPUT DETECTED" WHEN TRYING TO LOAD A DISC FOR A CASE. THE SITE REBOOTED THE SYSTEM, BUT DID NOT RESOLVE THE ISSUE. THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME. THE CAUSE WAS DUE TO AN INTERNAL CPU FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12085479 ↗MalfunctionMay 4, 2021Display or Visual Feedback Problem; Device Sensing Problem; Display or Visual Feedback Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SCREEN WAS BLANK AND THEY WERE NOT SEEING THEIR CT AFTER REGISTRATION. TECHNICAL SERVICES (TS) CLARIFIED THAT THEY WERE IN THE REGISTRATION TAB, THEY SUCCESSFULLY COMPLETED THEIR REGISTRATION WITH A TRACER PROBE AND IT SAID TO VERIFY REGISTRATION ACCURACY WITH KNOWN ANATOMICAL POINTS. THE SITE WAS ABLE TO ADVANCE TO THE NAVIGATION SCREEN. ON THE NAVIGATION SCREEN, THE EMITTER DETAILS SHOWED NIPT 0.2 GEOMETRY ERROR, STRAIGHT SUCTION AT 1.23. WHEN SURGEON PLACED INSTRUMENT IN DIVOT, "NOTHING HAPPENED." TECHNICAL SERVICES (TS) ADVISED TO SEE IF THEY COULD NAVIGATE WITH ANY OTHER INSTRUMENTS, SPECIFICALLY THE TRACER POINTER. THE REGISTERED NURSE (RN) DENIED BEING ABLE TO NAVIGATE WITH POINTER STATING "NO INSTRUMENTS WORK." TS ASKED IF THERE WAS ANOTHER SUCTION TO TRY, RN STATED THAT THEY HAD TRIED THEM ALL. THE SURGEON DECLINED FURTHER TROUBLESHOOTING HELP AND NAVIGATION WAS ABORTED, AND HAD NURSE END CALL. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 15 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770195 ↗
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 · TerminatedFusion 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 · TerminatedMACH 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-1585-2014 · Apr 24, 2014 · TerminatedINST 9731132 KIT CR REF FRAME DRIVER 5PK
- Z-1597-2014 · Apr 24, 2014 · TerminatedTRAJ GUIDE KIT, 9733065, BIOPSY, EXT
- Z-1578-2014 · Apr 24, 2014 · TerminatedBAG 9732315 MOUSE STERILE 15 PK
- Z-1595-2014 · Apr 24, 2014 · TerminatedSPHERES 8801071 1/TRAY 12PK
- Z-1596-2014 · Apr 24, 2014 · TerminatedSPHERES 8801075 5/TRAY 12PK
- Z-1594-2014 · Apr 24, 2014 · TerminatedSHUNT KIT 9733605 NON-INVASIVE
- Z-1598-2014 · Apr 24, 2014 · TerminatedTRAJ GUIDE KIT, 9733066, BIOPSY, INT
- Z-1582-2014 · Apr 24, 2014 · TerminatedDISP 9730951 STRL SPHERE, 5PK INSERT
- Z-1592-2014 · Apr 24, 2014 · TerminatedPIN, 9733235, 100MM, STERILE, PERC REF
- Z-1602-2014 · Apr 24, 2014 · TerminatedUPGRD PRGM 9734638 ADD AxiEM NAVIGATION
- Z-1584-2014 · Apr 24, 2014 · TerminatedENT PRGM 9734636 ADD FUSION NAV AxiEM
- Z-1599-2014 · Apr 24, 2014 · TerminatedTUMOR RES. PACK 9733553 AxiEM S.M.
- Z-1591-2014 · Apr 24, 2014 · TerminatedPATIENT TRACKER 9733534XOM ENT 1PK
…and 13 more.
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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