StealthStation S8 Platform 9735668 (UDI 00643169877016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169877016), received between Jun 28, 2018 and Apr 15, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 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 THE SYSTEM WAS UNABLE TO READ PATIENT DISCS. THE SYSTEM DISPLAYED "NO MEDIA DETECTED" WHEN THE TWO SEPARATE DISCS WERE INSERTED IN TO THE COMPACT DISC (CD) DRIVE. THERE WAS NO PATIENT INVOLVEMENT. DURING TROUBLESHOOTING, THE MANUFACTURER REPRESENTATIVE (REP) WAS UNABLE TO DOWNLOAD IMAGES. THE REP TESTED 6 DISCS IN TOTAL AND THEY WERE NOT ABLE TO LOAD. THE REP WAS ABLE TO LOAD THE IMAGE WITH THE CD, WITH AN EXTERNAL CD READER. WHEN TRYING TO DELETE THE EXTRA ITEMS THAT ARE ON THE CD, THE REP WAS UNABLE TO. ON THE CD THERE WAS A VIEWER SOFTWARE, AUTO-RUN SOFTWARE, COMMON LAUNCH, AND REPAIR ON THE DISC. DURING ADDITIONAL TROUBLESHOOTING, THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE EAR, NOSE, THROAT (ENT) SOFTWARE DISC WAS ALSO NOT RECOGNIZED AS MOUNTED BY THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841953 ↗
• MalfunctionFeb 18, 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 WHEN LOADING A SCAN THE SYSTEM BECAME UNRESPONSIVE. THE SYSTEM WAS REBOOTED AND BECAME UNRESPONSIVE A SECOND TIME. A HARD REBOOT WAS PERFORMED AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402767 ↗
• MalfunctionNov 11, 2024Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS SHOWING A LOCALIZER FAULTED MESSAGE WHILE IN THE APPLICATION. THE CAMERA ALSO HAD AN AMBER FAULTED LIGHT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652742 ↗
• MalfunctionOct 14, 2024Display or Visual Feedback Problem; No Device Output; Display or Visual Feedback Problem; No Device Output

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING DIFFICULTIES REGISTERING A PATIENT WHILE IN SURGERY. THE SITE WAS USING A FLAT EMITTER WITH THREE POINT TOUCH REGISTRATIONS. THE SYSTEM PROMPTED USER TO "TAP ON 3D MODEL TO UPDATE FIRST POINT" AND THE SITE WAS PRESSING THE FOOTSWITCH WHILE HOLDING TRACER POINTER AT PATIENT'S NOSE WITH NO CHANGE. TECHNICAL SERVICES (TS) HAD SITE OPENED TRACKING WINDOW TO ENSURE ABLE TO SEE BOTH PATIENT TRACKER AND INSTRUMENT. THE SITE ADJUSTED INSTRUMENT POSITION TO HAVE THE INSTRUMENT SHOWING UP IN THE TRACKING WINDOW. TS HELPED THE SITE FIGURE OUT THE SYSTEM WAS SET TO STATIONARY PROBE AND ATTEMPTED TO REGISTER BY HOLDING THE PROBE STILL. THE SITE WAS ABLE TO ADD THE 3 POINTS BUT THEN THE INSTRUCTIONS ON THE SCREEN WENT BLANK. THE PROGRESS BAR UNDER 3D MODEL INDICATED REACHING MINIMUM TRACE WAS NEXT, BUT THE INSTRUCTIONAL GRAPHIC TO THE LEFT OF IT STILL HAD THE 3 POINT TOUCH INSTRUCTIONS. TS RECOMMENDED TRYING TO HOLD TRACER IN ONE SPOT ON THE PATIENT ANATOMY TO ATTEMPT TO CONTINUE WITH TRACE REGISTRATION WITH NO CHANGE. TS THEN RECOMMENDED REBOOTING. THE SITE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444127 ↗
• MalfunctionJun 10, 2024Application Program Freezes or Fails to Launch; 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 WHILE IN A FESS PROCEDURE, THE SYSTEM BECAME UNRESPONSIVE. THE SITE PERFORMED A HARD REBOOT, AND THE ISSUE OCCURRED AGAIN. THE SITE PERFORMED ANOTHER HARD REBOOT AND THE ISSUE DID NOT REOCCUR. THE EVENT CAUSED A SURGICAL DELAY OF 5 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME. TROUBLESHOOTING INFORMATION WAS PROVIDED. IT WAS UNKNOWN IF PATIENT DATA WAS ROUTINELY REMOVED FROM THE SYSTEM. NO ERROR MESSAGES REPORTED. ADDITIONAL INFORMATION WAS LATER RECEIVED. THE MEDTRONIC REPRESENTATIVE (REP) CALLED IN ON SITE, CONFIRMED SYSTEM COULD BE UPGRADED TO LATEST APP INSTEAD OF AN UNINSTALL/REINSTALL. THE SYSTEM WAS STILL SEEING INTERMITTENT ISSUES. THE REP OPENED UP THE SYSTEM AND FOUND THE POWER CABLE NOT FULLY SEATED INTERNALLY AND THE BLACK STRAIN RELIEF ON POWER CABLE WAS MISSING WHERE CABLE COMES INTO THE NAVIGATION SYSTEM. THEY RE-SEATED THE CABLE AND THE SYSTEM SEEMED TO BE RESPONDING BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500548 ↗
• MalfunctionApr 19, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING AN EXTERNAL VENTRICULAR DRAIN (EVD) PLACEMENT, THE SYSTEM DISPLAYED, "LOCALIZER NOT CONNECTED." THE SURGEON OPTED TO ABORT THE ENTIRE PROCEDURE. THE PROCEDURE WAS ABORTED DURING PATIENT REGISTRATION PRIOR TO ANY INCISION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO KNOWN REPORTED IMPACT ON PATIENT OUTCOME. THE PATIENT WAS IN AN INTENSIVE CARE UNIT (ICU) BED PROCEDURE. THERE WAS NO GENERAL ANESTHESIA USED, JUST A STANDARD SEDATIVE. WHILE ONSITE, THE MANUFACTURER REPRESENTATIVE (REP) COULD NOT REPLICATE THE ISSUE WITH EITHER THE FLAT OR SIDE EMITTER. ONLY THE BREAKOUT BOX WAS PLUGGED IN WHEN THE REP WENT TO TROUBLESHOOT THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141135 ↗
• MalfunctionApr 2, 2024Failure to Read Input Signal; Failure to Shut Off; Application Program Freezes or Fails to Launch; Failure to Read Input Signal; Failure to Shut Off; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT  THE SYSTEM'S TOUCHSCREEN WAS NOT FUNCTIONING PROPERLY. THE SITE ATTEMPTED TO REBOOT THE SYSTEM AND THE SYSTEM WOULD NOT SHUT DOWN. THEY HAD TO HOLD THE POWER BUTTON FOR ABOUT 3 SECONDS TO GET THE CART TO FULLY SHUT DOWN. AFTER THEY TURNED IT BACK ON, NO ISSUES WERE OBSERVED. DELAY INFORMATION WAS NOR PROVIDED. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED ISSUE OCCURRED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WAS NO REPORTED DELAY TO THE CASE. THE SYSTEM BECAME UNRESPONSIVE WHEN LOADING A PATIENT DISC, NOT PERSAY THAT THE TOUCH SCREEN STOPPED WORKING. THE MANUFACTURER REPRESENTATIVE WAS UNABLE TO REPLICATE THE IT WHEN THEY PERFORMED THE SYSTEM CHECKOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020148 ↗
• MalfunctionMar 27, 2024Failure to Read Input Signal; Use of Device Problem; Application Program Freezes or Fails to Launch; Failure to Read Input Signal; Use of Device 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 TOUCH SCREEN WAS BECOMING UNRESPONSIVE. WHEN THEY WERE IN NAVIGATION AND THEY WENT TO TRY TO MAKE THE SCREEN BIGGER IT WOULD NOT WORK. THE MANUFACTURER REPRESENTATIVE TRIED TO USE THE MOUSE FROM THE SITE'S ON-SITE COMPUTER AND IT WORKED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988987 ↗
• MalfunctionMar 21, 2024Application Program Freezes or Fails to Launch; 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 SCREEN WOULD BECOME UNRESPONSIVE WHEN TRYING TO NAVIGATE THE SUCTION INSTRUMENT. IT WAS UNKNOWN IF THE CROSSHAIRS WENT RED. IT WAS NOTED BY A MANUFACTURING REPRESENTATIVE (REP) THAT THEY THOUGHT ALL THE SUCTIONS NAVIGATED BUT WITH ONE THE SCREEN WOULD BECOME UNRESPONSIVE. IT WAS NOTED THAT THE REST OF THE INSTRUMENTS NAVIGATED FINE. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956105 ↗
• MalfunctionOct 16, 2023Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE SETTING UP THE SYSTEM, IT WOULD BOOT TO A "LOCALIZER FAULTED" MESSAGE. THE MEDTRONIC REPRESENTATIVE (REP) CHECKED THE NDI TOOLBOX AND IT SHOWED BUMP FAULT, AS WELL AS TEMPERATURE FAULT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940385 ↗
• MalfunctionJun 29, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A PROCEDURE. IT WAS REPORTED THAT AN ERROR 64 MESSAGE APPEARED ON THE SCREEN AND THE SITE HAD TO REBOOT THE UNIT TO CARRY ON WITH THE CASE. THERE WAS NO PATIENT IMPACT. ON 2022-MAY-24 INTERFACE UPDATE: ADDITIONAL INFORMATION WAS RECEIVED THAT THIS OCCURRED DURING A CRANIAL PROCEDURE FOR A SUBDURAL HEMATOMA. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849448 ↗
• MalfunctionJan 18, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SITE WAS TRACING AND WERE NOT GETTING POINTS ON THE SIDE OF THE FACE FARTHEST FROM THE EMITTER. A MANUFACTURER REPRESENTATIVE TRIED RE-POSITIONING AND HOLDING THE EMITTER WHILE THE TRACE WAS HAPPENING, HOWEVER, IT WAS NOT POSSIBLE TO GET THAT SIDE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF NAVIGATION. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE. THE SITE HAD EDITED THE 3D MODEL AND HAD ALSO AUTO-REFINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262692 ↗
• MalfunctionNov 9, 2018Communication or Transmission Problem; Material Integrity Problem; Communication or Transmission Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE MONITOR HAD BEEN PHYSICALLY DAMAGED AND THE TOUCHSCREEN WAS NO LONGER WORKING. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8055335 ↗
• MalfunctionSep 6, 2018Imprecision; Poor Quality Image; Imprecision; Poor Quality Image

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION. IT WAS REPORTED THAT IMAGES WERE MISSING SLICES ALONG WITH BAD IMAGE QUALITY. SITE SUCCESSFULLY REGISTERED THE PATIENT BUT WERE INACCURATE WHEN VERIFYING REGISTRATION. AUTO-REFINE ATTEMPTED WITHOUT RESOLUTION. THERE WAS NO IMPACT TO PATIENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7853264 ↗
• MalfunctionJun 28, 2018Application Interface Becomes Non-Functional Or Program Exits Abnormally; No Display/Image; Electrical /Electronic Property Problem; Application Interface Becomes Non-Functional Or Program Exits Abnormally; No Display/Image; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT WHILE NAVIGATING, THE SYSTEM WENT TO THE SPLASH SCREEN AND THEN STATED NO VIDEO DETECTED. THE REPRESENTATIVE CHECKED THE MONITOR SETTINGS AND IT WAS ON HDMI. THE REPRESENTATIVE RESEATED THE CABLES COMING FROM THE MONITOR, WITH NO RESOLVE. IT WAS NOTED THAT THE COMPUTER WAS NOT RUNNING. THE REPRESENTATIVE THEN LOOKED AT THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND REPORTED THAT ONLY THE V6-11 WERE GREEN. NAVIGATION WAS ABORTED. THERE WAS NO REPORTED DELAY IN SURGERY AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647061 ↗

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