StealthStation S8 9735670Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000355128), received between Jan 10, 2022 and Mar 31, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SAID LOCALIZER FAULTED. THE AMBER LIGHT WAS ON AND NOT BLINKING. THE GREEN LIGHT WAS OFF. THERE WAS NO PATIENT INVOLVEMENT. THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX STATED "ILLUMINATOR HARDWARE FAULT. RETURN FOR SERVICE." GOING TO "FILE" AND RESETTING TO FACTORY DEFAULTS DID NOT CHANGE THE SITUATION. ATTEMPTING TO TAKE A PHOTO WITH THE CAMERA BY USING THE CAMERA ICONLIKEWISE DID NOT CHANGE THE SITUATION. A HARD REBOOT WAS PERFORMED, BUT THIS ALSO DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745279 ↗
• MalfunctionOct 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem; Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. THERE WAS A LESS THAN ONE HOUR DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392373 ↗
• MalfunctionAug 18, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA HAD THE GREEN AND YELLOW LIGHTS ILLUMINATED. SYSTEM STILL TRACKED AND NAVIGATED. THERE WAS NO PATIENT INVOLVEMENT. DURING TROUBLESHOOTING IT WAS DISCOVERED THAT THERE WAS AN SYSTEM CONTROL UNIT (SCU) CONNECTION FAILURE IN THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834097 ↗
• MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE STATED THAT ONE SIDE OF THE SPINE WAS ACCURATE BUT THE OTHER SIDE WAS NOT ACCURATE. THEY ABORTED NAVIGATION AND PERFORMED THE REST OF THE CASE WITHOUT NAVIGATION. THREE IMAGING ACQUISITION SYSTEM (IAS) SPINS WERE TAKEN OF THE PATIENT.  ALLEGEDLY THE PERC PIN WAS PLACED IN INSECURE BONE WHICH MAY HAVE IMPACTED THE ACCURACY OF THE NAVIGATION. NO FURTHER INFORMATION AVAILABLE AT TIME OF CALL. MEDTRONIC IMAGING WAS ABORTED. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY WAS 1-2 CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531659 ↗
• MalfunctionJun 26, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT A NON-MEDTRONIC IMAGING SYSTEM IMAGE WAS ROTATED 45 DEGREES WHEN TRANSFERRED OVER TO THE NAVIGATION SYSTEM. DURING TROUBLESHOOTING, THEY TOOK ANOTHER IMAGE, AND IT APPEARED STRAIGHT ON THE NAVIGATION SYSTEM. DELAY INFORMATION WAS NOT PROVIDED. IT WAS UNKNOWN IF THERE WAS AN IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337433 ↗
• MalfunctionMay 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INACCURACY AFTER REGISTRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968571 ↗
• MalfunctionFeb 23, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS HAVING ISSUES WITH NOT BEING ABLE TO TRACK THE PATIENT REFERENCE FRAME AND IMAGING SYSTEM TRACKER AT THE SAME TIME. THE SYSTEM COULD TRACK THE PATIENT REFERENCE FRAME OR THE IMAGING SYSTEM TRACKER INDIVIDUALLY EVEN THOUGH THEY WERE IN THE SAME FIELD OF VIEW (FOV) THAT THE CAMERA SAW. THE SYSTEM WAS REBOOTED AND THE ISSUE RESOLVED. THERE WAS A 5 TO 10 MINUTE SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME. IT WAS NOTED THAT THE ISSUE HAD OCCURRED A FEW MONTHS PRIOR TO REPORT AND WAS RESOLVED. IT WAS CONFIRMED THAT THE CUSTOMER WAS USING NEW CLEAN SPHERES AND HAD ATTEMPTED ADJUSTING THE ANGLE AND POSITION OF THE CAMERA IN AN ATTEMPT TO RESOLVE THE ISSUE. THE ENVIRONMENT WAS ALSO NOTED TO HAVE BEEN CHANGED AND THE ONLY THING THAT RESOLVED THE ISSUE WAS REBOOT ING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442778 ↗
• MalfunctionJan 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WOULD NOT SHOW THE COMPUTER-AIDED DESIGN (CAD) MODEL OF THE INSTRUMENT DURING A POSTERIOR FUSION. THE CAD MODEL APPEARED IN T1 VIEW, BUT NOT T2 VIEW. THE SITE USED COMPUTER TOMOGRAPHY (CT) CT-FLOURO REGISTRATION. TROUBLESHOOTING WAS PERFORMED, AND THE SITE MOVED BACKWARDS AND FORWARDS IN THE SOFTWARE, REBOOTED, AND REREGISTERED THE PATIENT WHICH RESOLVED THE ISSUE. SURGICAL DELAY WAS LESS THAN 1 HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233596 ↗
• MalfunctionJan 23, 2025Erratic or Intermittent Display; Failure to Read Input Signal; Application Program Problem; Device Sensing Problem; Application Program Freezes or Fails to Launch; Erratic or Intermittent Display; Failure to Read Input Signal; Application Program Problem; Device Sensing Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT NAVIGATION OF THE AUTOMATED TRAJECTORY GUIDANCE UNIT WAS INTERRUPTED. DURING THE CASE THE WARNING SIGN APPEARED ON THE CONTROL UNIT AND THE TARGETING UNIT PREVENTING THE AUTOMATED TRAJECTORY GUIDANCE UNIT TO GO INTO FINAL TRAJECTORY POSITION. IT HAD TO BE HOMED SEVERAL TIMES AND MOVED TO TRAJECTORY UNTIL FINALLY IT LOCKED ON THE TRAJECTORY. DURING THIS GLITCH, THE TRACKER DISPLAY ON THE NAVIGATION SYSTEM FLICKERED BETWEEN RED AND GREEN (BOTH THE TRACKER AND THE PATIENT REFERENCE) FIRST AN ISSUE WITH THE SPHERES WAS EXPECTED. BUT AFTER THE ERROR THE REST OF THE SURGERY WENT WELL WITH NO BIG TRACKING ISSUES AND ALSO TESTS AFTER THE SURGERY DID NOT SHOW OBVIOUS ISSUES WITH THE SPHERES. THE OPERATING ROOM LIGHTS WERE MOVED OUT OF THE WAY, TRACKING SPHERES WERE CLEANED AND CHECKED THAT THEY WERE FIT SNUG ON THE TRACKER BUT THIS DID NOT SOLVE THE ISSUE. AFTER A FEW TIMES STARTING THE AUTOALIGNMENT FROM THE HOME POSITION AGAIN THE SYSTEM FINALLY LOCKED INTO THE TRAJECTORY POSITION. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218325 ↗
• MalfunctionDec 10, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A SPINE CASE INVOLVING THE USE OF A NAVIGATION SYSTEM, THE INSTRUMENT DISPLAYED THE EXPECTED COMPUTER-AIDED DESIGN (CAD) IN TRAJECTORY 2 BUT NOT IN TRAJECTORY 1, OCCURRING TWICE. THE ISSUE AROSE AFTER CHANGING THE TOOL CARD TO AN INTERBODY INSERTER INSTRUMENT, RESULTING IN THE CAD MODEL NO LONGER BEING VISIBLE, ALTHOUGH A "GREEN LINE FOR THE PROJECTION" WAS STILL PRESENT. THIS PROCEDURAL/DEVICE-RELATED ISSUE NECESSITATED A SYSTEM REBOOT AND RE-VERIFICATION OF ALL INSTRUMENTS, WHICH RESOLVED THE ISSUE FOR THE REMAINDER OF THE PROCEDURE. THE EVENT CAUSED AN APPROXIMATE 10-MINUTE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898038 ↗
• MalfunctionSep 30, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A TOTAL SHOULDER REPLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED A LOCALIZER FAULTED. THE BREAK OUT BOX HAD AN AMBER LIGHT NEXT TO THE X. IN TRACKING DETAILS, NONE OF THE INSTRUMENTS COULD BE TRACKER OR APPEARED IN THE TRACKING WINDOW. THE SYSTEM HAD A SIDE EMITTER PLUGGED IN AT THE TIME OF CALL. THIS ISSUE OCCURRED DURING REGISTRATION. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT TO PATIENT OUTCOME. MEDTRONIC IMAGING AND NAVIGATION WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334666 ↗
• MalfunctionSep 11, 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 WHILE ON SITE TO UPGRADE THE SYSTEM, THE CAMERA CART FUNCTIONED AS INTENDED, BUT THE MAIN CART MONITOR WAS NOT TURNING ON. THERE WAS NO MEDTRONIC SPLASH SCREEN, DURING BOOT UP ON THE MAIN CART. LED ON THE POWER BUTTON LIT UP BLUE. NO ERROR/SIGNAL ON THE MONITOR. POWER CABLE TO THE MONITOR LOOKED SEATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189695 ↗
• MalfunctionJun 30, 2023Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SEEMED TO BE OFF BY 2-3 MM IN THE FIRST SPIN THEN ABOUT 1 MM OFF IN THE SECOND SPIN. AS THE CASE WENT ON, THE SYSTEM SEEMED TO BECOME MORE INACCURATE. THE ORANGE INSTRUMENT THAT WASN'T USED IN THE CASE ALSO POPPED UP LIKE 4-5 TIMES DURING THE CASE FOR A FEW SECONDS. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239390 ↗
• MalfunctionJan 13, 2023Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A C2-T2 CASE USING THE CRANIAL REFERENCE FRAME, THERE WERE INACCURACIES AFTER TRANSFERRING THE IMAGING SYSTEM SPIN. THE SURGEON STATED THAT THE SYSTEM WAS A COUPLE MILLIMETERS DEEP AND TO THE SIDE. NO FURTHER INFORMATION WAS PROVIDED. THE SITE SPUN AGAIN AND GOT A VERY SIMILAR RESULT. THE SURGEON PROCEEDED WITH THE CASE. 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 16157454 ↗
• MalfunctionSep 20, 2022Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON SYSTEM'S INSTALL, THE SYSTEM'S CAMERA CART WAS SHOWING NO INPUT DETECTED WHILST THE MAIN CART APPEARED NORMAL. HE ALSO NOTED THE CAMERA AUDIBLY BEEPED AND TURNED ON AND THE CART SEEMED TO BE GETTING POWER JUST NOT COMMUNICATION. NO PATIENT PRESENT. NO DELAY TO CASE. TROUBLESHOOTING WAS PERFORMED. THE MANUFACTURER REPRESENTATIVE (REP) CHECKED THE INPUT SETTINGS ON THE MONITOR TO VERIFY THE CAMERA CART WAS IN THE CORRECT MODE, AND RESTARTED THE SYSTEM BUT THERE WAS NO CHANGE. THE PROBABLE CAUSE WAS DETERMINED TO BE THE DP CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454296 ↗
• MalfunctionAug 15, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE NAVIGATING, THE SCREEN FROZE ON BOTH MONITORS AND WAS UNRESPONSIVE. THE MOUSE COULD NOT BE LOCATED BUT THE SCREEN BEGAN RESPONDING AGAIN WITH NO INTERVENTION. ONLY THE IMAGING SYSTEM SPIN WAS BEING NAVIGATED, NO MERGE. THE VIEW WAS NOT ZOOMED IN. INSTRUMENTS WERE TRACKING BUT NO BUTTONS WERE ABLE TO BE SELECTED. THE EVENT CAUSED A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224111 ↗
• MalfunctionJan 10, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL RESECTION. IT WAS REPORTED THAT THE CAMERA CART MONITOR TOOK A MOMENT TO POWER ON AND DURING REGISTRATION THE SYSTEM DISPLAYED AN ERROR 64. THE MANUFACTURER REPRESENTATIVE CONFIRMED THE CABLES WERE SEATED. THE ERROR WAS RESOLVED BY A REBOOT AND THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO PATIENT IMPACT REPORTED AND A SURGICAL DELAY OF LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211257 ↗

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