StealthStation S8 9735669 (UDI 00643169838918)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,831 adverse event reports that list this exact device (DI 00643169838918), received between Jul 6, 2017 and Sep 29, 2026 — classified as 23 injuries, 1,808 malfunctions.

The most frequently reported specific device problem is “Imprecision” (377 reports).

2 other recalls cover devices cleared under the same FDA submission (K162309); 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 25 most recent of 1,831 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934119 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the system's flat emitter had a section where the cable was becoming frayed. The Medtronic representative (rep) provided a picture of the damage and believed the issue was caused due to wear and tear. The system was six years old and had never replaced the flat emitter before. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884190 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Medtronic received information regarding a navigation system being used in an unknown procedure. It was reported that the tracing was off and not aligned. Patient presence unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715463 ↗
• MalfunctionSep 1, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545556 ↗
• MalfunctionAug 12, 2026Device Sensing Problem; Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224524 ↗
• MalfunctionJun 22, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT INTERFACE CABLE WAS DAMAGED DUE TO NORMAL WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25584168 ↗
• MalfunctionMay 26, 2026Application 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 WHENEVER THE MANUFACTURER REPRESENTATIVE (REP) ATTEMPTED TO LOG IN TO THE CLINICAL APPLICATION, THE SYSTEM WOULD PAUSE FOR A FEW MOMENTS BEFORE KICKING THEY BACK TO THE LOGIN SCREEN. WHILE THE REP WAS USING THE CLINICAL APPLICATION, THE SCREEN WENT UNRESPONSIVE. THE REP PERFORMED A HARD REBOOT OF THE SYSTEM AND THE ISSUE WAS RESOLVED UPON BOOT. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS THE SOLID STATE DRIVE (SSD). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281042 ↗
• MalfunctionMay 18, 2026Device Sensing Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM KEPT GOING UNRESPONSIVE, EVEN ON LOG IN. THERE WAS NO PATIENT IMPACT AND LESS THAN AN HOUR OF DELAY. ADDITIONAL INFORMATION AS RECEIVED. IT WAS REPORTED THAT THE SYSTEM WENT UNRESPONSIVE DURING NAVIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25208612 ↗
• MalfunctionMay 5, 2026Device Sensing Problem

  THE ISSUE OCCURRED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WAS AROUND A 15 MINUTE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082379 ↗
• MalfunctionApr 21, 2026Display or Visual Feedback Problem; Mechanical Problem; Failure to Read Input Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S MONITOR WAS CRACKED. THIS ISSUE WAS A CONTINUATION OF ANOTHER CASE, IN WHICH THE MONITOR WAS NEVER REPLACED. THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE SCREEN APPEARED TO BE ZOOMED IN. ONLY THREE OF THE FOUR ROWS APPEARED WHEN THE REP BROUGHT UP A KEYBOARD. ADDITIONALLY, CERTAIN PARTS OF THE TOUCH SCREEN WERE OFF. WHEN THE REP PRESSED A BUTTON, ANOTHER ONE NEARBY ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941586 ↗
• MalfunctionApr 3, 2026Use of Device Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN ONSITE THE MANUFACTURER REPRESENTATIVE (REP) BOOTED UP THE SYSTEM, AND A LOW PERFORMANCE ERROR DISPLAYED. TO TROUBLESHOOT THE REP REPORTED DELETING 25 PATIENTS FROM SYSTEM AND EACH PATIENT HAD A LOT OF SCANS THAT WERE NOT RELEVANT TO NAVIGATION. THE REP REPORTED OVER 800GB AVAILABLE (UNKNOWN WHAT IT WAS PRIOR TO DELETING PATIENTS) AND LOG LEVEL SET TO INFO. THE REP REBOOTED THE SYSTEM AND THE ERROR NO LONGER APPEARED WHEN IN A PROCEDURE. IT WAS AGREED TO MONITOR FOR REOCCURRENCE. NO PATIENT WAS PRESENT. IT WAS REPORTED THAT THE SYSTEM WAS INTERMITTENTLY DISPLAYING THE MESSAGE "WARNING, LOW SYSTEM MEMORY." THE SITE CHECKED THE SYSTEM STORAGE AND FOUND THAT THE NURSES HAD DELETED ALL BUT THREE PATIENTS OFF THE SYSTEM. IT WAS REPORTED THAT THE "SD" CARD WAS REPLACED, THE REP WILL PULL LOGS TO SUBMIT AT THAT TIME. THE MESSAGE WAS OCCURRING INTERMITTENTLY. THE ISSUE WAS INTERMITTENT. REP SAW THE MESSAGE WHILE TOGGLING THROUGH MENU STEPS AND LOOKING AT PATIENT SCANS. NO INSTRUMENTS OR HARDWARE PARTS WERE IN USE WHEN REP OBSERVED THE MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781843 ↗
• MalfunctionMar 25, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE ONSITE, THE FLAT EMITTER CABLE WAS TAPED AND LIKELY DAMAGED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688634 ↗
• MalfunctionMar 24, 2026Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT IMAGES DOWNLOADED FROM PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) WIRELESSLY WERE OFTEN MISSING SLICES, AND THE SYSTEM DESIGNATES THEM AS NOT OPTIMAL FOR THE SYSTEM. THIS SAME ISSUE OCCURRED ON A DIFFERENT SYSTEM. TROUBLESHOOTING WAS PERFORMED, IT WAS MENTIONED WIFI WAS UNRELIABLE AND SPOTTY IN THE HOSPITAL. THE PROBABLE CAUSE WAS FOUND WITHIN THE RESOLUTION FOR A DIFFERENT CASE THAT INDICATED THIS WAS AN ISSUE WITH THE HOSPITAL'S WIFI. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673983 ↗
• MalfunctionMar 23, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM BOOTED TO A BLACK SCREEN ON THE MONITOR. THE MEDTRONIC REPRESENTATIVE STATED THAT THERE WAS NO MEDTRONIC SPLASH SCREEN. THE REP RESEATED THE MONITOR POWER CABLE, BUT THE ISSUE PERSISTED. THE REP STATED THAT THE V6 CONNECTION ON THE UNINTERRUPTIBLE POWER SUPPLY (UPS) FELT LOOSE. ONCE RESEATED, SHE FELT THE LATCH CLICK AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664940 ↗
• MalfunctionMar 23, 2026Electrical /Electronic Property Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FLAT EMITTER WRAP WAS DAMAGED. WORK ORDER HAD SHOWN THAT WIRING WERE EXPOSED ON THE CABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663877 ↗
• MalfunctionMar 19, 2026Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER UPLOADING SCANS TO THE SYSTEM AND ATTEMPTING TO SHUTDOWN TO USE LATER IN THE DAY, THE SYSTEM'S MONITOR DISPLAYED 'NO VIDEO DETECTED.' TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES (TS) HAD THE SITE HARD REBOOT THE SYSTEM, UNPLUG FROM THE WALL POWER FOR A MINUTE, AND RESEAT THE ETHERNET CABLE FROM THE SYSTEM TO THE WALL TO COMMUNICATE TO THE PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS). THEN, TS HAD THE SITE PLUG IN THE SYSTEM TO THE WALL POWER AGAIN AND ATTEMPT TO BOOT. THE SITE REPORTED THE SYSTEM BOOTED, SCANS WERE STILL UPLOADED AND SHUTDOWN AS NORMAL. THE ISSUE WAS RESOLVED, AND THE SYSTEM WAS FUNCTIONING AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642219 ↗
• MalfunctionMar 13, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S FLAT EMITTER HAD A BENT PIN IN THE LEMO CONNECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591886 ↗
• MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CASE CONTINUED WITHOUT RESOLUTION. IT WAS REPORTED THAT NAVIGATION WAS ABORTED AND THE CASE WAS CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519550 ↗
• MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING A CASE, AFTER THE TRACE, IT WAS NOTED THAT THE GREEN CIRCLE FOR THE TRACE WAS WHERE THE SURGEON WANTED IT TO BE. WHEN CHECKING VERIFICATION, HE NOTICED THE ACCURACY WAS WAY OFF FROM WHERE HE THOUGHT IT WAS. HE WENT BACK TO REDO THE TRACE AND FOUND THAT HE WAS EXPERIENCING DIFFICULTY COMPLETING REGISTRATION. AT SOME POINT DURING THE REGISTRATION HE FOUND THAT THE INSTRUMENT WAS TRACKING POINTS IN FLOATING SPACE ABOVE THE PATIENT. THE SURGEON REBOOTED THE SYSTEM AND AFTER WAS ABLE TO COMPLETE A SUCCESSFUL REGISTRATION AND WAS ABLE TO CONTINUE WITH THE CASE. THERE WAS A LESS THAN ONE HOUR SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502992 ↗
• MalfunctionMar 3, 2026Use of Device 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 SITE WAS UNABLE TO VERIFY THEIR INSTRUMENTS. THE INSTRUMENT TRACKED WAS GREEN WHEN IN THE FIELD-OF-VIEW (FOV) OF THE FLAT EMITTER. THE PATIENT TRACKER WAS ALSO GREEN. AFTER POSSIBLY REMOVING SOMETHING, THE FOREHEAD WAS ABLE TO REGISTER BUT THAT WAS IT. THE CLOSER THEY GOT TO THE NASAL ON THE SKIN OF THE PATIENT (NOT INSIDE OF THE NASAL CAVITY), THE INSTRUMENT WOULD GO RED. TECHNICAL SERVICES (TS) ASKED WHAT THE GEOMETRY ERROR WAS AND SITE STATED THAT THEY WERE AT 2.7 WHEN THEY WERE ON THE SKIN. TS FOUND THAT VALUE TO BE HIGH. WHEN TS ATTEMPTED TO DUPLICATE IT ON A HEAD MODEL, TS WAS AT ABOUT 0.91 OR LESS. ONLY WHEN A FIST AND HALF ABOVE THE DEMO HEAD WOULD TS GET A 2.7 GEOMETRY ERROR. TS WOULD LIKE THE REP TO PERFORM A SYSTEM CHECKOUT AND CHECK THE SITE'S INSTRUMENTS AND FLAT EMITTER. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HR. THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT A MANUFACTURER REPRESENTATIVE (REP) VISITED THE SITE TO PERFORM TROUBLESHOOTING. THERE WERE 2 DIFFER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498270 ↗
• MalfunctionMar 2, 2026Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE IMAGES DOWNLOADED FROM ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) WIRELESSLY WERE OFTEN MISSING SLICES, AND THE SYSTEM DESIGNATES THEM AS NOT OPTIMAL FOR NAVIGATION SYSTEM. IT WAS DETERMINED THAT THE PROBABLE CAUSE WAS AN ISSUE WITH THE HOSPITAL WIFI RELIABILITY BUT OTHERWISE COULD BE AN ISSUE WITH THE SYSTEM'S WIFI ENDPOINT. IT WAS DETERMINED THAT THE SECOND NAVIGATION SYSTEM WAS ALSO HAVING ISSUES DOWNLOADING FULL SCANS VIA WIRELESS CONNECTION AND WIRED CONNECTION WAS FUNCTIONING. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483902 ↗
• MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE EXPERIENCED AN ALLEGED INACCURACY DURING A FESS CASE. SITE NOTED THAT DURING REGISTRATION, SYSTEM WOULD REGISTER TRACE POINTS IN THE AIR OFF THE PATIENT'S HEAD. ONCE IN NAVIGATION, SITE OBSERVED ~5MM INACCURACIES WHEN WORKING ON THE PATIENT'S LEFT. SITE REPORTED NAVIGATION TO BE ACCURATE WHEN WORKING ON PATIENT'S RIGHT. TROUBLESHOOTING WAS PERFORMED, IT RECOMMENDED THAT THE MANUFACTURER REPRESENTATIVE (REP) REINSTALL SOFTWARE APPLICATION. SIDE EMITTER WAS RECENTLY REPLACED ON THIS SYSTEM, SO REP WILL LOAN SITE A BREAKOUT BOX AND CONTINUE TO MONITOR ISSUE FOR HARDWARE TROUBLESHOOTING PURPOSES. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429531 ↗
• MalfunctionFeb 19, 2026Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR DISPLAY CHANGED TO A NO VIDEO DETECTED. THE CLINICAL SERVICES REPRESENTATIVE (CS) CONFIRMED THAT THE SOURCE INPUT HAD NOT BEEN CHANGED FROM HIGH DEFINITION MULTIMEDIA INTERFACE (HDMI) AND THIS ISSUE HAD NOT OCCURRED BEFORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389165 ↗
• MalfunctionFeb 18, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAS A CHIP IN THE MONITOR SCREEN. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379431 ↗
• MalfunctionFeb 18, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD DIFFICULTY TRACKING INSTRUMENTS AND WAS UNABLE TO TRACK WHILE IN SURGERY. THE SITE DID NOT KNOW WHICH INSTRUMENTS WERE IN USE. TROUBLESHOOTING WAS PERFORMED. WHILE THE SYSTEM WAS IN THE BIOMED SHOP, THE SITE BIOMED ENGINEER CONFIRMED THAT THERE WERE NO LOCALIZER ERRORS AND NO AMBER LIGHT ON THE CAMERA WHICH LIKELY CONFIRMED THERE WAS NOTHING WRONG WITH THE SYSTEM. THE ISSUE WAS LIKELY RELATED TO THE INSTRUMENTS IN USE AT THE TIME. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS THE INSTRUMENTS. THIS ISSUE CAUSED AN UNKNOWN SURGICAL DELAY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2024 · Mar 26, 2024 · Open, Classified
  Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
• Z-1995-2020 · Aug 9, 2019 · Terminated
  Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen