StealthStation S8 Platform 9735665 (UDI 00763000272760)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000272760), received between May 26, 2020 and Mar 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Unexpected Shutdown; Excessive Heating

  2026-MAR-3 00874299 (HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SHUT DOWN IN THE MIDDLE OF THE CASE. THE MANUFACTURING REPRESENTATIVE (REP) WAS UNSURE IF IT WAS THE MAIN CART OR THE CAMERA CART OR BOTH THAT SHUT DOWN. TROUBLESHOOTING WAS PERFORMED. THE REP REPORTED THAT AFTER PERFORMING A BATTERY TEST ON THE SYSTEM, THE MAIN CART BATTERY AND CAMERA CART BATTERY WERE BOTH AT 100% BEFORE UNPLUGGING FROM WALL POWER. THE REP REPORTED AFTER UNPLUGGING FROM WALL POWER, BOTH BATTERY PERCENTAGES HELD CHARGE AROUND 75% FOR THREE MINUTES BEFORE PLUGGING THE SYSTEM BACK IN. TECHNICAL SERVICES (TS) HAD THE REP OPEN THE BACK OF THE MAIN CART AND VISUALLY INSPECT THE MAIN CART BATTERY. THE REP REPORTED THAT THE BATTERY HAD VISIBLE BLACK SPOTS ON IT AND FELT HOT IN TEMPERATURE. TS PREDICTED THE ISSUE WAS RELATED TO THE MAIN CART BATTERY LEAKAGE. THERE WAS NO IMPACT ON PATIENT OUTCOME AND LESS THAN AN HOUR OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519605 ↗
• MalfunctionOct 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A CRANIAL TUMOR RESECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336340 ↗
• MalfunctionAug 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE IMAGE ON THE SCREEN APPEARED "FLIPPED" AFTER REGISTRATION. SITE REPORTED THAT WHEN SURGEON TOUCHED THE RIGHT-HAND SIDE, THE SYSTEM DISPLAYED THAT SHE WAS TOUCHING ON THE LEFT-HAND SIDE. SITE ABORTED USE OF NAVIGATION AND MEDTRONIC IMAGING. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738127 ↗
• MalfunctionJul 31, 2025Application Program Problem; Device Sensing Problem; Application Program Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRE-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE WAS ABLE TO SUCCESSFULLY REGISTER THE PATIENT WITH THE REGISTRATION PROBE AND SWITCHED IT OUT FOR A CURVED SUCTION INSTRUMENT, AND SAID THEY WERE NO LONGER ABLE TO NAVIGATE. THERE WAS AN ERROR ON SCREEN THAT STATED, "INSTRUMENT CANNOT BE ABLE TO BE USED IN NAVIGATION.". THIS WOULD OCCUR FOR EVERY INSTRUMENT THEY TRIED EXCEPT THE REGISTRATION PROBE. TECHNICAL SERVICES ASKED IF THEY WERE STILL ON THE REGISTRATION PAGE. THE SITE MOVED TO THE NAVIGATION PAGE AND THEN ALL INSTRUMENTS WERE ABLE TO BE NAVIGATED - ISSUE RESOLVED ON CALL. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677771 ↗
• MalfunctionJul 31, 2025Mechanical Problem; Application Program Problem; Device Sensing Problem; Mechanical Problem; Application Program Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS CLARIFIED THAT SURGERY WAS NOT ABORTED. THE PROCEDURE WAS DELAYED BY ONE HOUR AND THE SITE USED A DIFFERENT CAMERA CART TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676310 ↗
• MalfunctionJan 30, 2024Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LOCAL REPRESENTATIVE (CC) HAD TO POWER THE CAMERA CART ON SEPARATELY. THE CAMERA CART SHUT OFF. TO GET THROUGH THE CASE, THEY SWAPPED CAMERA CARTS. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SITE DID NOT KEEP THE CARTS CONNECTED WHEN IN STORAGE. WHEN THE CC WENT TO TURN THE SYSTEM ON VIA THE MAIN CART POWER BUTTON THE CAMERA CART CAME UP WITH NO ISSUE. AFTER LETTING BOTH BATTERIES CHARGE TO 100%, THE CC PERFORMED A BATTERY STRESS TEST. AFTER THREE MINUTES OF THE SYSTEM BEING UNPLUGGED THE MAIN CART BATTERY WAS AT 80% AND THE CAMERA CART BATTERY WAS AT 15%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607708 ↗
• MalfunctionApr 28, 2022Material Integrity Problem; Output Problem; Application Program Freezes or Fails to Launch; Material Integrity Problem; Output 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 DURING PREVENTATIVE MAINTENANCE (PM) THE CAMERA WAS SHOWING A FAULT LIGHT. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED. THE AMBER LIGHT ON THE CAMERA WAS INTERMITTENTLY COMING ON AND OFF, HOWEVER THE CAMERA CONTINUOUSLY TRACKED. IN THE NDI TOOL BOX, THERE WAS A FIRMWARE MISMATCH ERROR WITH THE SCU. THE NETWORK CABLE THAT PLUGGED INTO THE BACK OF THE CAMERA WAS KINKED, SO THE MANUFACTURER REPRESENTATIVE (REP) BYPASSED THE CAMERA TO THE POE WITH A KNOWN WORKING NETWORK CABLE TO TEST, BUT THERE WAS NO CHANGE. THE REP ALSO USED THE KNOWN GOOD NETWORK CABLE TO GO FROM THE SCU TO THE CHECKPOINT TO SEE IF IT WAS A NETWORK CABLE ISSUE, BUT THERE WAS STILL NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240697 ↗
• MalfunctionFeb 11, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE CAMERA HAD A FAULT LIGHT. THE SITE SWITCHED TO A DIFFERENT S8 FOR THE CASE. THE CAMERA BOOTED NORMALLY WHEN THE MANUFACTURER REPRESENTATIVE USED IT. THERE WAS NO AMBER LIGHT. EVERYTHING WAS FUNCTIONING AS INTENDED. THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR AND THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THIS WAS A POSTERIOR CERVICAL DECOMPRESSION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517671 ↗
• MalfunctionAug 18, 2021Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS UNABLE TO SEE ANY SPHERES AND THE O-ARM TRACKER. THE REPRESENTATIVE RECOMMENDED DISCONNECTING THE MAIN CART AND CAMERA CART UNTIL THE NETWORK CONNECTION LOST MESSAGE APPEARS ON THE CAMERA CART. AT THIS POINT THE CAMERA CART WAS RE-CONNECTED AND COMMUNICATION AND TRACKING WAS REESTABLISHED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT AND DELAY WAS LESS THAN AN HOUR. ADDITIONAL INFORMATION RECEIVED, IT WAS STATED THAT IN TROUBLESHOOT AN AMBER LIGHT DISPLAYED ON THE CAMERA. TECHNICAL SERVICE WALKED THE REPRESENTATIVE THROUGH NDI TOOLBOX TO CHECK THE STATUS. THE REPRESENTATIVE REPORTED "SCU" CONNECTION FAILURE. THEN THEY CHECKED THE SELF TEST AND THE PSU AND SCU WAS RED AND NOT CONNECTED. THEY THEN REMOVED THE COVERS AND CHECKED THE ETHERNET CONNECTIONS ON BOTH ENDS. AFTER RESEATING BOTH THE ENDS, THEY CHECKED THE SELF TEST STATUS AGAIN, ERROR MESSAGES WERE STILL RED. THE REPRESENTATIVE TRIED ANOTHER ETHERNET CABLE AND CHECKED THE SELF TEST, ERROR MESSAGES WENT AWAY. THE REPRESENTATIVE NOTICED THE ETHERNET CABLE BEING KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336065 ↗
• MalfunctionMay 26, 2020Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS UPDATED THAT THE SYSTEM WAS TESTED TO SEE IF THE PROBLEM PERSISTED. THE SETTINGS WERE CHECKED ACCORDING TO THE 3RD PARTY DEVICE DOCUMENT. AT INSTALLATION A REPRESENTATIVE WAS ON SITE SUPPORTING. DURING THE INSTALLATION WAS REALIZED THAT IT SEEMED TO HELP TO SWITCH THE CLASS MODALITY IN THE DICOM SETTINGS OF THE MICROSCOPE AND THEN THE SYSTEM WAS ABLE TO TRANSFER. THIS SEEMED TO RESET THE CONNECTION PROBLEM AND AVOIDED NEEDING TO RESTART THE SYSTEM. THE SITE ALWAYS RESTARTED BOTH SYSTEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10090014 ↗

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