Fusion™ ENT Image Guidance System 9733560XOM (UDI 00613994380005)Recalls & reported problems
Medtronic Navigation, Inc. · CART 9733560XOM FUSION EM SYSTEM · 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 image guidance system is a navigation system used during surgery to track instruments on screen. Reports most often describe the system behaving differently than expected, inaccurate tracking, and startup or software error messages. The FDA database lists 1,316 reports, with 20 injuries 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
- 1,316
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,316 adverse event reports that list this exact device (DI 00613994380005), received between Sep 21, 2016 and Feb 11, 2025 — classified as 20 injuries, 1,296 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (245 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
- Device Operates Differently Than Expected245
- Human-Device Interface Problem193
- Imprecision161
- Application Interface Becomes Non-Functional Or Program Exits Abnormally154
- Mechanical Problem153
- Communication or Transmission Problem138
- Computer Software Problem104
- Device Stops Intermittently99
Patient problems
- No Patient Involvement545
- No Known Impact Or Consequence To Patient419
- No Consequences Or Impact To Patient221
- No Clinical Signs, Symptoms or Conditions139
- Cerebrospinal Fluid Leakage7
- Iatrogenic Source6
- Complaint, Ill-Defined2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 1,316 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 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 WHEN LOADING THE PATIENT EXAM VIA COMPACT DISC (CD), THE SYSTEM DISPLAYED AN ERROR MESSAGE OF, "UNABLE TO INTERPRET HEADER DATA." SITE NOTED THAT THE SYSTEM DISPLAYED THE SAME MESSAGE ON STRUCTURED AND UNSTRUCTURED DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) WHEN LOADING. TROUBLESHOOTING INCLUDED HAVING SIDE LOAD THE CD ONTO A COMPUTER. SITE NOTED THERE WERE SEVERAL IMAGER VIEWING APPLICATIONS, AN AUTORUN FILE, AND A README IN THE EXAM. SITE UNABLE TO DELETE THESE FILES, AS THE DISC WAS READ ONLY. SITE TRANSFERRED THE DICOM FOLDER AND THE DICOMDIR FILE ONTO A FAT32 USB. THE SYSTEM RECOGNIZED THE FILE, BUT THEN DISPLAYED AN ERROR MESSAGE "NO SOURCE DATA FOUND." THE SITE WAS INSTRUCTED TO ALTER THE UNIVERSAL SERIAL BUS (USB) WITH SEVERAL FILE PERMUTATIONS. THE EXISTING FOLDER STRUCTURE WENT FROM DICOM TO PAT001 TO STUDY01 TO 400 DICOM FILES. THE STIE TRIED TO MOVE THE 400 DICOM FILES INTO THE PAT001 FOLDER, BUT THE ISSUE PERSISTED. SITE TRIED MOVING THE 400 DICOM FILES TO THE DICOM FOLDER, AND THE ISSUE PERSISTED. SITE NOTED THAT REBURNING A CD WAS NOT AN OP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356464 ↗MalfunctionNov 8, 2024Device Sensing Problem; Human-Device Interface Problem; Device Sensing Problem; Human-Device Interface Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SITE HAD DIFFICULTY TRACKING THEIR INSTRUMENTS. THE EMITTER DETAILS INITIALLY SHOWED ALL RED FOR THE FOUR PORTS IN USE. TECHNICAL SERVICES HAD THE SITE HOLD AN INSTRUMENT DIRECTLY IN FRONT OF THE EMITTER, AND IT STARTED TRACKING AND WAS GREEN. IT WAS INITIALLY ALSO A FLAT PANEL UNDERNEATH THE PATIENT, HOWEVER, THEY WERE USING A SIDE EMITTER. THE SITE WAS ABLE TO REGISTER FOR THE MOST PART, BUT STATED THAT THE FAR SIDE OF THE PATIENT'S HEAD WAS NOT PICKING UP ANY POINTS. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644593 ↗MalfunctionSep 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 DISPLAYED "NO INPUT DETECTED" ON BOOTUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20170288 ↗MalfunctionAug 22, 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 BOOTED UP INTO THE "NO INPUT DETECTED" ERROR. NO PATIENT WAS PRESENT. THE PROBABLE CAUSE WAS SUSPECTED TO BE EITHER THE CMOS (COMPLEMENTARY METAL OXIDE SEMICONDUCTOR) BATTERY OR COMPUTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20028644 ↗MalfunctionJun 21, 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 WHEN PERFORMING PLANNED MAINTENANCE (PM), AND ADJUSTING THE CONTRAST AND BRIGHTNESS OF THE MONITOR, THE REPRESENTATIVE SELECTED "FACTORY DEFAULT" SETTING, EVEN THOUGH THAT FIXES THE MONITOR RESOLUTION AND COLOR, THE SCREEN WAS NOW SHIFTED TO THE RIGHT. THE SYSTEM WAS REBOOTED, AND FACTORY SETTINGS WERE RELOADED. THE DVI CABLES WERE RESEATED. THE REPRESENTATIVE CHANGED THE HORIZONTAL SETTING TO 0 AND IT MOVED THE SCREEN CLOSER TO THE LEFT BUT STILL WAS 1-2INCES AWAY FROM BEING CENTERED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19586635 ↗MalfunctionMay 15, 2024Connection Problem; Device Sensing Problem; Connection 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 THERE WERE INSTRUMENTS WERE NOT VERIFYING. THEY RESTARTED THE SYSTEM AND CHANGED OUT THE PATIENT TRACKER FOR THE REGISTRATION PROBE TO WORK. THE MOVED THE EMITTER AROUND AND THE INSTRUMENT WOULD NOT VERIFY ANYWHERE. EMITTER GOES RED AFTER USING THE MICRODEBRIDER AND CHECKING EMITTER DETAILS THEY WERE ABLE TO VERIFY OTHER INSTRUMENTS. IT WOULD GO RED AND THEN GREEN BUT THEN STAYED GREEN. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19321058 ↗MalfunctionApr 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN ABSCESS DRAINAGE PROCEDURE. IT WAS REPORTED THAT NAVIGATION WAS ALLEGEDLY INACCURATE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIVE MINUTES DUE TO THIS ISSUE BEFORE THE SURGEON OPTED TO ABORT THE USE OF NAVIGATION. HOWEVER, THE PROCEDURE WAS STILL COMPLETED DESPITE THE REPORTED INACCURACY. THE AMOUNT OF INACCURACY WAS 5-10 MILLIMETERS. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042546 ↗MalfunctionJan 23, 2024Application Program Problem; Application Program Problem
ONLY PATIENT OUTCOME WAS A DELAY. WHILE SHE COULDN¿T SAY FOR SURE SHE GUESSED MAYBE 20-30 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18566235 ↗MalfunctionDec 18, 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 THERE WAS A BLACK SCREEN AND THAT THE SYSTEM HAD BEEN DOWN FOR A COUPLE MONTHS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344402 ↗MalfunctionDec 18, 2023Application Program Problem; Device Sensing Problem; Application Program Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ERROR ON THE SYSTEM STATING LOCALIZER NOT CONNECTED WITH A RED X OVER EMITTER ICON ON SOFTWARE. THE SITE WAS UNABLE TO TRACK ANYTHING. THERE WAS NO PATIENT INVOLVEMENT. THE PROBABLE CAUSE WAS NOTED TO BE THE EMITTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344299 ↗MalfunctionDec 12, 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'S MONITOR DISPLAYED A BLACK SCREEN. MULTIPLE CMOS BATTERY RESETS WERE PERFORMED AND RESEATED MONITOR CABLES WHICH DID NOT AFFECT THE CONDITION. IT WAS ALSO CONFIRMED THAT THE SYSTEM'S FANS WERE STILL FUNCTIONAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18310761 ↗MalfunctionNov 30, 2023Unexpected Shutdown; Unexpected Shutdown
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SHUT OFF RANDOMLY BY ITSELF. THE SITE DID NOT KNOW IF THERE WAS A PATIENT PRESENT, THERE WAS NO ADDITIONAL DETAILS ON THE ISSUE THAT THE SITE WAS HAVING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOTED THAT IT NEEDED TO BE UNDERSTOOD IF THE MONITOR REMAINED ON WHEN THE SYSTEM SHUT DOWN OR IF THE SYSTEM WENT COMPLETELY BLACK. IT WAS NOTED THAT THE PROBABLE CAUSE WAS EITHER A BAD POWER SUPPLY, BAD COMPUTER AND OR A BAD MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241453 ↗MalfunctionOct 19, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED, THAT THE ISSUE OCCURRED, INTRAOPERATIVELY IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). AND SURGICAL DELAY WAS REPORTED, AS LESS THAN ONE-HOUR. THERE WAS NO IMPACT TO PATIENT'S OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17964968 ↗MalfunctionOct 9, 2023Mechanical Problem; Device Sensing Problem; Unintended Application Program Shut Down; Mechanical Problem; Device Sensing Problem; Unintended Application Program Shut Down
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EMITTER ON THE SYSTEM WAS CRACKED AND THE BUZZING SOUND COMING OUT OF IT WHEN ACTIVE WAS NOT SMOOTH. THE MANUFACTURER REPRESENTATIVE ALSO REPORTED THAT AFTER REGISTERING HER DEMO HEAD THE SYSTEM WOULD UNEXPECTEDLY GO BACK TO THE REGISTRATION SCREEN, AS IF THE SOFT KEY ON THE PATIENT TRACKER HAD BEEN ACTIVATED, BUT THE INSTRUMENT WAS ACTUALLY IN THE DIVOT. THE MOST LIKELY / SUSPECTED CAUSE OF THE ISSUE WAS THE EMITTER WAS NO LONGER TRACKING ACCURATELY DUE TO DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17896712 ↗MalfunctionMay 25, 2023Environmental 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 DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE AND SHUT DOWN. THE SURGEON REBOOTED THE SYSTEM AND RESUMED SURGERY. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17002078 ↗MalfunctionMay 22, 2023Imprecision; Imprecision
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE NAVIGATION SYSTEM WAS INACCURATE. THE INSTRUMENT WAS IN ETHMOID NAVIGATION, BUT SAID IT WAS IN BRAIN. THERE WAS LESS THAN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973514 ↗MalfunctionApr 5, 2023Environmental Compatibility Problem; Environmental Compatibility Problem
ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT THERE WAS A DELAY OF 10 MINUTES AND THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682216 ↗MalfunctionMar 28, 2023Device Sensing Problem; Material Integrity Problem; Device Sensing Problem; Material Integrity Problem
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT PRESENT AT THE TIME THIS ISSUE OCCURRED WITH THE NAVIGATION SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16627939 ↗MalfunctionFeb 13, 2023Connection Problem; Connection Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S EMITTER WAS NOT CONNECTED WHILE IN SURGERY. TECHNICAL SERVICES (TS) WALKED THE SITE THROUGH TROUBLESHOOTING. THEY WALKED THROUGH THE EM INTERFACE WHERE THE DRIVE/NOISE FIELDS WERE BLANK. WHEN CHECKING THE POWER FIELDS, THE +33, +12, +5, AND -5 VDC FIELDS WERE ALL FAULTED. THE USE OF MEDTRONIC NAVIGATION WAS ABORTED. THERE WAS NO SURGICAL DELAY OR PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16362507 ↗MalfunctionDec 7, 2022Material Integrity Problem; Material Integrity Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A PROCEDURE. IT WAS REPORTED THAT THE SITE DROPPED THE EMITTER AND NOTICED A CRACK IN IT. THEY CONTINUED ON WITH A CASE AND REPORTED THAT "IMAGE QUALITY WAS POOR" DURING THE CASE. DELAY IN SURGERY AND PATIENT OUTCOME WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15933895 ↗MalfunctionNov 4, 2022Imprecision; Application Program Freezes or Fails to Launch; Imprecision; 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 BECAME UNRESPONSIVE WHEN LOADING THE PATIENT DISK. THE SYSTEM WAS POWERED OFF AND ON, AND THE SURGEON WAS ABLE TO REGISTER. WHEN THEY VERIFIED ACCURACY IT WAS OFF, INACCURACY WAS UNKNOWN. NAVIGATION WAS ABORTED. THERE WAS A DELAY OF LESS THAN ONE HOUR AND NO IMPACT TO THE PATIENT. IT WAS NOTED THE CASES FOR THE REST OF THAT WEEK WERE CANCELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15738147 ↗MalfunctionOct 17, 2022Imprecision; Imprecision
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY DURING A CASE. WHEN USING THE SYSTEM TO NAVIGATE THE PATIENT'S LEFT SIDE, IT SEEMED TO BE INACCURATE 2-4MM LATERAL. ON THE PATIENTS RIGHT SIDE, THE SYSTEM SEEMED ACCURATE. THE SITE ATTEMPTED A RE-REGISTRATION AND IT WAS STILL OFF. IT WAS NEAR THE END OF THE CASE SO THEY DID NOT NEED TO ABORT THE CASE BUT NAVIGATION WAS NO LONGER USED. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED A LESS THAN 1 HOUR DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15614721 ↗MalfunctionOct 11, 2022Device Sensing Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE INSTRUMENTS STOPPED TRACKING NEAR THE END OF THE CASE. THE INSTRUMENTS WERE WORKING AT THE BEGINNING OF THE CASE. EVERYTHING TURNED RED TOWARDS THE END OF THE CASE AND THE TOOLS WERE NOT READING. THEY REBOOTED THE SYSTEM AND THE ISSUE DID NOT RESOLVE. TROUBLESHOOTING WAS PERFORMED AND THE MANUFACTURER REPRESENTATIVE WALKED THE SITE THROUGH TESTING TO MAKE SURE THE INSTRUMENTS WOULD TRACK. THE INSTRUMENTS WERE TRACKING FINE. THE REP GAVE THE SITE INSTRUCTION ON HOW TO TROUBLESHOOT THE EM INTERFERENCE DURING A CASE IF THE ISSUE OCCURRED AGAIN. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579576 ↗MalfunctionOct 11, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE DURING NAVIGATION. THERE WAS NO PATIENT IMPACT AND A DELAY OF LESS THAN ONE HOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15577983 ↗MalfunctionOct 6, 2022Connection Problem; Application Program Freezes or Fails to Launch; Connection Problem; Application Program Freezes or Fails to Launch
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING SURGERY, THE SYSTEM DISPLAYED AN EMITTER NOT CONNECTING ERROR. THIS PERSISTED AFTER REBOOTS AND THERE WAS NOT OTHER EM EQUIPMENT TO TEST WITH. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15551607 ↗
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 · 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-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-1584-2014 · Apr 24, 2014 · TerminatedENT PRGM 9734636 ADD FUSION NAV AxiEM
- Z-1582-2014 · Apr 24, 2014 · TerminatedDISP 9730951 STRL SPHERE, 5PK INSERT
- Z-1579-2014 · Apr 24, 2014 · TerminatedBIOPSY NEEDLE KIT, 9733068, PASSIVE
- Z-1587-2014 · Apr 24, 2014 · TerminatedKIT, 9731427, THORACIC TACTILE PROBES
- Z-1578-2014 · Apr 24, 2014 · TerminatedBAG 9732315 MOUSE STERILE 15 PK
- Z-1601-2014 · Apr 24, 2014 · TerminatedTUMOR RESECTION KIT 9733608 SKULL MOUNT
- Z-1580-2014 · Apr 24, 2014 · TerminatedBIT 9733516 2.9mm DRILL STERILE
- Z-1581-2014 · Apr 24, 2014 · TerminatedDISP 9730950 STRL SPHERE, 1 PK INSERT
- Z-1583-2014 · Apr 24, 2014 · TerminatedDRAPE 9732722 TUBE STERILE O-ARM 20PK
- Z-1585-2014 · Apr 24, 2014 · TerminatedINST 9731132 KIT CR REF FRAME DRIVER 5PK
- Z-1591-2014 · Apr 24, 2014 · TerminatedPATIENT TRACKER 9733534XOM ENT 1PK
- Z-1599-2014 · Apr 24, 2014 · TerminatedTUMOR RES. PACK 9733553 AxiEM S.M.
- Z-1590-2014 · Apr 24, 2014 · TerminatedPAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
…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
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
- Fusion™ ENT Image Guidance System 9733560Medtronic Navigation, Inc. · Neurological stereotaxic Instrument458 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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