N/A 9735894 (UDI 00763000423179)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000423179), received between Mar 13, 2023 and Jan 16, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR COULD NOT DISPLAY AFTER BOOTUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092845 ↗
• MalfunctionDec 16, 2025Display 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 OCCASIONALLY EXPERIENCED A LOSS OF VIDEO SIGNAL, RESULTING IN A BLACK SCREEN. IT WAS NOTED THE ISSUE WAS RELATED TO THE USB-C TO HDMI ADAPTER AND REPLACING IT WITH A DIFFERENT BRAND CABLE RESOLVED THE PROBLEM TEMPORARILY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821068 ↗
• MalfunctionDec 1, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT A MAGNETIC RESONANCE IMAGE (MRI) SERIES HAD INCORRECT ORIENTATION, FOR EXAMPLE THE AXIAL VIEWS WERE LABELED AS CORONAL, AND LEFT/RIGHT WERE FLIPPED. AFTER SOME UNSUCCESSFUL TROUBLESHOOTING, SURGEON OPTED TO MOVE FORWARD WITH THE CASE DESPITE IMAGE ISSUES. PATIENT PRESENT, SURGICAL DELAY PF LESS THAN ONE HOUR. NO KNOWN IMPACT TO PATIENT OUTCOME. FURTHER TROUBLESHOOTING WAS PERFORMED, TECHNICAL SERVICES (TS) HAD THE FIELD REPRESENTATIVE (REP) USE THE ROTATE FUNCTION IN THE IMAGES SERIES. THIS SEEMED TO FIX SOME OF THE IMAGE ISSUES, BUT NOT OTHERS. THE REP WAS UNABLE TO TRY THE REORIENT FUNCTION BEFORE THE SURGEON OPTED TO MOVE FORWARD. THE PROBABLE CAUSE WAS NOTED TO BE THE IMAGES MAY HAVE BEEN LABELED INCORRECTLY FORM THE SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679602 ↗
• MalfunctionNov 3, 2025Display or Visual Feedback Problem; Application Program Problem; Display 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 A POWER OUTAGE AT THE SITE, THE SYSTEM WOULD ONLY DISPLAY "NO SIGNAL DETECTED" ON THE MONITOR. IT WAS CONFIRMED THAT THE SYSTEM WAS NOT PLUGGED INTO AN ISOLATED CIRCUIT, AND THE SYSTEM COMPUTER POWERED ON. THE SITE WAS UNSUCCESSFUL USING SOFTKEYS TO CHANGE THE VIDEO INPUT TO HIGH-DEFINITION MULTIMEDIA INTERFACE (HDMI). THE CABLES WERE RESEATED WITH NO RESOLUTION. THERE WAS NO PATIENT INVOLVEMENT. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE MONITOR WAS DISPLAYING "NO VIDEO DETECTED" AFTER ATTEMPTING TO CHANGE THE SOFTKEYS VIDEO MONITOR INPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459523 ↗
• MalfunctionJun 11, 2025Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT REINSTALLING THE TOOLS DB, OR MICROCAL (WHICH INCLUDES THE TOOLS DB) WOULD FIX THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184900 ↗
• MalfunctionMay 21, 2025Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE COULD NOT EXPORT PATIENT EXAMS VIA DVD FOR USE ON THE NAVIGATION SYSTEM BECAUSE THE DVD DRIVE WASN'T WORKING. HAVING TO USE UNIVERSAL SERIAL BUS (USB) INSTEAD. THERE WAS NO PATIENT INVOLVEMENT. THE PLANNING STATION WAS NOTED TO NEED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059818 ↗
• InjuryApr 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED: THE SYSTEM BEING USED WAS A PLANNING STATION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 21935002 ↗
• MalfunctionFeb 25, 2025Display 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 WORKSTATION SCREEN WAS NOT ILLUMINATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459491 ↗
• MalfunctionFeb 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INCORRECTLY SET IMAGE SOURCE ON THE MONITOR. THE IMAGE WAS NOT DISPLAYED, THERE WAS ONLY A NOTIFICATION OF NO INPUT SIGNAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367658 ↗
• MalfunctionNov 4, 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 COULD NOT START. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597827 ↗
• MalfunctionOct 7, 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 MONITOR WAS NOT SWITCHING ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384198 ↗
• MalfunctionSep 30, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Delayed Program or Algorithm Execution; Application Program Problem; Application Program Freezes or Fails to Launch; Delayed Program or Algorithm Execution

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DID NOT BOOT UP. AFTER RESTARTING THE SYSTEM IT DID NOT BOOT UP AND REMAINED STUCK LOADING THE SOFTWARE WITH AN ERROR ON THE AUDIO DEVICE GIVING THE MESSAGE "CENTRAL PROCESSING UNIT (CPU) STUCK FOR 20 SECONDS". THE NEXT STEP WAS TO SHUT DOWN THE SYSTEM AND DISCONNECT IT FROM THE POWER PLUG FOR A WHILE, THE SYSTEM STARTED AGAIN. IT SEEMED SLOWER TO THE SITE. THE NEXT STEP WAS TO REPLACE THE COMPUTER AND SSD TO GIVE A FINAL RESOLUTION AND A STABLE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332264 ↗
• MalfunctionSep 18, 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 WHEN TURNING ON, THE SYSTEM WOULD NOT BOOT. EVEN AFTER REBOOTING SEVERAL TIMES, THE ISSUE REMAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248662 ↗
• MalfunctionSep 17, 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 THERE WERE BOOT UP ISSUES. AFTER INSTALLING APPLICATION VERSION 2.1 ON THE SYSTEM AND THEN PERFORMING A REBOOT, THE SYSTEM BOOTED TO THE MESSAGE "FAILED TO START PULSE AUDIO SYSTEM SERVER...WATCHDOG: BUG: SOFT LOCKUP - CPU STUCK...". TROUBLESHOOTING WAS PERFORMED. THE LOCAL REPRESENTATIVE (FSE) HAD CONFIRMED THAT THE SYSTEM WAS ON OPERATING SYSTEM 2.0.3 PRIOR TO INSTALLING APPLICATION VERSION 2.1, AND THERE WERE NO REPORTED ISSUES DURING THE INSTALLATION. THE FSE PERFORMED ANOTHER REBOOT. THE SYSTEM THEN DISPLAYED DIFFERENT COMMANDS ALL WITH "OK" STATUS, FOLLOWED BY MULTIPLE LINES STATING "SPURIOUS RESPONSE". THE SYSTEM WAS UNABLE TO PROGRESS PAST THIS SCREEN. THE FSE PERFORMED ANOTHER REBOOT WITH NO EFFECT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239964 ↗
• MalfunctionSep 17, 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 AFTER TURNING THE PLANNING STATION AND MONITOR ON, THE MONITOR WOULD SHOW A "NO VIDEO SIGNAL" MESSAGE. TROUBLESHOOTING WAS PERFORMED. THE LOCAL REPRESENTATIVE (REP) UNPLUGGED THE POWER FROM THE POWER SUPPLY (PS) AND TURNED IT BACK ON AGAIN, BUT THAT DID NOT RESOLVE THE ISSUE. THEY TRIED "3-2-3-2-1" ON THE MONITOR, BUT IT WOULD NOT ACCESS THE MENU AT ALL. THEY TRIED JUST HITTING THE MENU BUTTON IN CASE THE TOUCH "BUTTONS" WERE NOT LOCKED, BUT THAT DID NOT WORK. IT WAS NOTED THAT THERE WAS NO OTHER MONITOR TO TRY TO PLUG INTO. THEY RESEATED ALL VIDEO CABLES, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238133 ↗
• MalfunctionSep 12, 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 PLANNING STATION (PS) WAS NOT BOOTING PROPERLY. THE DISPLAY SCREEN SHOWED THE SAME "PAGE." A HARD REBOOT WAS DONE, HOWEVER, THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202035 ↗
• 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 THAT THE SYSTEM WAS DISPLAYING AN UNENDING STRING OF TEXT UPON BOOTUP. THE SYSTEM HAD REPORTEDLY BEEN RUNNING FOR 2+ HOURS. AFTER A HARD REBOOT, THE ISSUE RESOLVED AND THE SYSTEM BOOTED UP NORMALLY. IT WAS SUSPECTED THE ISSUE COULD HAVE BEEN CAUSED BY A FAULTY SOLID STATE DRIVE (SSD) OR COMPUTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171184 ↗
• MalfunctionSep 9, 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 SITE WAS INFORMING OF INTERMITTENT FAILURE OF THE NAVIGATION SYSTEM TO GET TO LOGIN PROMPT. THE SYSTEM WAS STUCK IN BOOT SEQUENCE WITH ERROR "FAILED TO START PULSEAUDIO SYSTEM SERVER" AND "WATCHDOG BUG: SOFT LOCKUP, CPU#2 STUCK FOR 22S". THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED. THE REP WAS ABLE TO START THE APPLICATION FROM THE GRUB MENU. THE SITE WAS ABLE TO BACKUP PLANNED CASES, BUT THE SAME ERROR WOULD OCCUR AFTER SHUTDOWN/STARTUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168590 ↗
• MalfunctionSep 6, 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 COMPUTER DID NOT START, THIS WAS AN INTERMITTENT PROBLEM. THE NEXT STEP WAS TO REPLACE THE COMPUTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158476 ↗
• MalfunctionSep 3, 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 THERE WAS AN UBUNTU ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125491 ↗
• MalfunctionAug 15, 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 AN UBUNTU ISSUE WAS SEEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990799 ↗
• MalfunctionMar 13, 2023Computer Software Problem; Application Program Problem; Environmental Compatibility Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Problem; Environmental Compatibility Problem; Unexpected Shutdown; 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 DID NOT WORK. WHEN THE SYSTEM WAS TURNED ON, IT CONTINUES TO RESTART ITSELF SHOWING ERROR MESSAGES AND MAKING IT IMPOSSIBLE TO START ANY SOFTWARE. THE NEXT STEP WAS TO REPLACE THE HARD DISK. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529384 ↗

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