StealthStation S8 Platform 9735665 (UDI 00763000272739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,542 adverse event reports that list this exact device (DI 00763000272739), received between Nov 25, 2019 and Sep 25, 2026 — classified as 2 deaths, 36 injuries, 1,504 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (332 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 25 most recent of 1,542 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904964 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that when downloading a large (400 slice) image in preparation for a cranial case, the images were split up into multiple files each containing a handful of the image set. Deleting the image files and re-downloading the images resolved the issue. It was believed that the issue was due to an interruption in the electronic Picture Archiving and Communication Systems (PACS) network connection. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755109 ↗
• MalfunctionSep 10, 2026Mechanical Problem; Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704085 ↗
• MalfunctionAug 26, 2026Mechanical Problem; Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456150 ↗
• MalfunctionAug 19, 2026Display or Visual Feedback Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328223 ↗
• MalfunctionAug 17, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268687 ↗
• MalfunctionJun 19, 2026Mechanical Problem; Application Program Problem; Naturally Worn

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S FLAT EMITTER WAS MALFUNCTIONING, RESULTING IN A "LOCALIZER FAULTED" ERROR MESSAGE IN THE SOFTWARE. THERE WAS NO PATIENT INVOLVEMENT. THE PROBABLE CAUSE WAS NORMAL WEAR AND TEAR AS THERE WAS NO PHYSICAL DAMAGE. THE ISSUE RESOLVED WHEN THE SIDE EMITTER WAS PLUGGED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563796 ↗
• MalfunctionMay 14, 2026Electrical /Electronic Property Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE AXIEM BREAKBOX (BOB) WAS DAMAGED. THE CABLE HAS BEEN DETACHED FROM THE MAIN BOX AND EXPOSED THE WIRES. THE CLINICAL SPECIALIST (CS) DID NOT HAVE ANY DETAILS AS TO HOW THIS DAMAGED OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173158 ↗
• MalfunctionMay 12, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MAIN CART MONITOR WAS BLACK AFTER EVERYTHING BOOTED UP NORMALLY AND WAS MOVING THE SYSTEM. THE SITE USED ANOTHER SYSTEM FOR THE CASE. DURING TROUBLESHOOTING, THE CLINICAL SPECIALIST (CS) REPORTED THAT THE BACK COVERS ON BOTH MONITORS HAD BEEN REMOVED, LEAVING CABLES EXPOSED. THE CS WIGGLED THE HIGH-DEFINITION MULTIMEDIA INTERFACE (HDMI) CABLE ON THE BACK OF THE MAIN CART MONITOR AND REPORTED THAT IT WAS LOOSE. WHEN CS MOVED THE HDMI CABLE, THE VIDEO WOULD FLICKER IN AND OUT. THE CS ALSO REMOVED THE BACK COVER OF THE MAIN CART. THE CONNECTIONS ON THE COMPUTER APPEARED CORRECT AND NO ERROR LIGHTS WERE ON IN THE UNINTERRUPTABLE POWER SUPPLY (UPS). THE CS WIGGLED CABLES ON THE BACK OF THE COMPUTER BUT COULD NOT GET THE VIDEO ISSUES TO APPEAR. TECHNICAL SERVICES NOTED THE LIKELY CAUSE WAS THE MAIN CART MONITOR HAD A DAMAGED PORT. IT WAS REPORTED THAT A NURSE TURNED THE SYSTEM ON, THE SCREEN WAS BLACK. THEY COULD HEAR FANS. SO METIMES, THE MONITOR FUNCTIONED AS INTENDED. THE SCREEN INTERMITTENTLY WENT BLACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150574 ↗
• MalfunctionMay 8, 2026Display or Visual Feedback Problem; Application Program Problem; Connection Problem; Device Sensing Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER A MANUFACTURER REPRESENTATIVE (REP) INSTALLED THE CAMERA TO ADDRESS THE LOCALIZER FAULTED COMPLAINT IN A DIFFERENT CASE, A SLIGHTLY DIFFERENT ISSUE OCCURRED. THE SYSTEM KEPT ALTERNATING BETWEEN "LOCALIZER NOT CONNECTED" AND NORMAL TRACKING IN THE CLINICAL APP. WHILE ALTERNATING, THE LIGHTS ON THE CAMERA SWITCHED BETWEEN SOLID GREEN AND NO LIGHTS. IT WAS NOTED THAT WHEN THE REP ARRIVED ON SITE, THE POE ETHERNET CABLE THAT HAD AN ISSUE IN ANOTHER CASE HAD ALREADY BEEN REPLACED. WHEN THE REP CALLED TO TROUBLESHOOT THE ISSUE, THE SYSTEM HAD STOPPED ALTERNATING AND WAS SOLIDLY ON "LOCALIZER NOT CONNECTED." THERE WERE NO LIGHTS ON THE CAMERA. THE REP OPENED UP THE BACK OF THE CAMERA CART AND NOTICED THAT THE POWER OVER ETHERNET (POE) LIGHT WAS RED. GIVEN THAT THE ETHERNET CABLE HAD RECENTLY BEEN REPLACED IN A DIFFERENT CASE, TECHNICAL SERVICES (TS) SUSPECTED THAT PERHAPS THE ETHERNET CABLE WAS KINKED OR PINCHED IN A VERY DELICATE WAY. WITH A SPARE ETHERNET CABLE, REP PULLED OUT THE CHASSIS OF THE CAMERA CART AND PLUGGED THE NEW CAMERA DIRECTLY INTO THE POE. HOWEVER,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128329 ↗
• MalfunctionMay 4, 2026Electrical /Electronic Property Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE POWER CABLE WAS DAMAGED AND FRAYED. THERE WERE WIRES EXPOSED ON THE CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071058 ↗
• MalfunctionMay 1, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING SERVICING, IT WAS FOUND THAT THE ETHERNET CABLE THAT CONNECTS TO THE CAMERA WAS DAMAGED/FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059371 ↗
• MalfunctionApr 3, 2026Incorrect, 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 WHEN THE SURGEON WAS WORKING AT T9, THEY SUSPECTED THAT THE NAVIGATION WAS OFF. THEY VERIFIED THE SUSPICION BY PLACING THE AWL AGAINST THE KNOWN MIDLINE STRUCTURE AND THE SCREEN SHOWED THAT THEY WERE SEVERAL MILLIMETERS OFF TO THE SIDE. AT THIS POINT THEY WERE USING A DRILL AND THAT WAS ALSO NOT WORKING, SO THEY HAD TO USE A MANUAL METHOD. A SCAN CONFIRMED THE PLACEMENT OF REVISED SCREWS. IT WAS NOTED THAT THE "NAVIGATION SYSTEM DID NOT MEET THE SURGEON'S STANDARDS TO COMPLETE SCREW PLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781831 ↗
• MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS ALLEGEDLY INACCURATE BY 2-3MM. THE SITE WAS PERFORMING A C2-T2 FUSION USING CRANIAL FRAME WITH ARTICULATING ARM TO MAYFIELD, NOT ATTACHING TO SPINUS PROCESS. THIS ISSUE OCCURRED INTRA-OPERATIVELY AND CAUSED A LESS THAN ONE HOUR DELAY IN THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769387 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS CAUSED BY A SHIFT IN THE PATIENT REFERENCE FRAME. THE SITE HAS BEEN USING "Z DRAPES" WHICH IS A THIRD PARTY DRAPE THAT IS A CLEAR WRAP THE SITE WRAPPED THE PATIENT IN. THE DRAPE WAS PUTTING PRESSURE ON THE PATIENT REFERENCE FRAME, WHICH THEN SHIFTED THE PATIENT REFERENCE FRAME DOWN. THE AMOUNT OF INACCURACY WAS 2-5MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743109 ↗
• MalfunctionMar 30, 2026Use of Device Problem; Application Program Problem; Device Sensing Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED A "LOW PERFORMANCE" ERROR WHILE ATTEMPTING TO TRACK THE MICROSCOPE DOG BONE (TRACKER ATTACHED TO THE MICROSCOPE). THERE WAS LESS THAN AN HOUR DELAY, AND NO IMPACT ON PATIENT OUTCOME. ADDITIONAL TROUBLESHOOTING WAS PERFORMED. THE SYSTEM WAS HOOKED UP TO THE MICROSCOPE AND TRACKING DOG BONE, BUT THE MANUFACTURER REPRESENTATIVE (REP) WAS UNABLE TO REPLICATE WITH RESIN HEAD OR WITH PAST REGISTRATION OF COMPLAINT PATIENT. IMAGING SLICES REFERENCED INCLUDED 1MM X 1.12MM (AXIAL), 4.4MM X 4.0MM (SAGITTAL), 0.50MM X 1.0MM (SAGITTAL), AND 3.0MM X 3.0MM (AXIAL), WITH SOME EXAMS NOTED AS NOT OPTIMAL FOR THE NAVIGATION SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SYSTEM HAS PROGRESSED TO PROMPTING 'LOW PERFORMANCE' ERROR AND THEN BECOMING UNRESPONSIVE. TECHNICAL SERVICES (TS) RECOMMENDED UNINSTALLING AND REINSTALLING THE SOFTWARE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT AFTER REINSTALLING THE SOFTWARE, THE SAME 'LOW PERFORMANCE' ERROR PERSISTED. IT WAS NOTED THAT THE SITE DELETES PATIENT DATA EVERY WEEK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719428 ↗
• MalfunctionMar 26, 2026Incorrect, 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 THERE WAS AN ALLEGED INACCURACY DURING NAVIGATION. IT IS UNKNOWN HOW LARGE OR IN WHAT DIRECTION THE INACCURACY WAS. THIS WAS A TRAUMA CASE. THE SURGERY WAS ABORTED DUE TO AN UNSPECIFIED PATIENT ISSUE. THERE WAS NO KNOWN IMPACT ON PATIENT OUTCOME. THE EXTENT OF SURGICAL DELAY (IF ANY) IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701338 ↗
• MalfunctionMar 23, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT UPON BOOT, THE MAIN CART MONITOR REMAINED BLACK. THE CAMERA CART MONITOR FULLY BOOTED, AND THE SITE WAS ABLE TO LOG IN TO THE APPLICATION, BUT THE MAIN CART MONITOR REMAINED COMPLETELY BLACK. THE SITE REBOOTED THE SYSTEM SEVERAL TIMES BUT THE MAIN CART MONITOR WOULD NOT COME ON. THE SITE CHECKED CONNECTIONS INTO THE BACK OF THE MONITOR BECAUSE THE BACK OF THE MONITOR CABLE COVER WAS ALREADY MISSING FROM THE SYSTEM. THIS DID NOT RESOLVE THE ISSUE. THIS ISSUE OCCURRED PRE-OPERATIVELY AND CAUSED LESS THAN AN HOUR DELAY IN THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24668715 ↗
• MalfunctionMar 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INACCURACY WAS OVER 2 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663514 ↗
• MalfunctionMar 18, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CABLE FOR THE INSTRUMENT INTERFACE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630259 ↗
• MalfunctionMar 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  2026-MAR-12 (B)(4) (REP, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A SACROILIAC AND THORAC OLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A L4-L4 FUSION, THE GUIDEWIRES WERE INACCURATE BY 2-3MM LATERALLY. AFTER PERFORMING ANOTHER SPIN, ALL GUIDEWIRES WERE ACCURATE. THIS ISSUE OCCURRED INTRA-OPERATIVELY AND CAUSED LESS THAN AN HOUR DELAY IN THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627867 ↗
• MalfunctionMar 16, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS TRACKING INTERMITTENTLY WHEN USING EM. TROUBLESHOOTING WAS PERFORMED, CLINICAL SPECIALIST (CS) COULD NOT REPLICATE ISSUE, IT WAS SUSPECTED THE ISSUE WAS POOR PLACEMENT OF THE EMITTER. 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 24606444 ↗
• MalfunctionMar 11, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA CART MONITOR WENT BLACK AND THEN CAME BACK ON BY ITSELF. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE (REP) DID NOT NEED TO LOG BACK IN. IT RETURNED TO WHERE SHE WAS IN THE SOFTWARE. TROUBLESHOOTING WAS PERFORMED. THE REP CONFIRMED THERE WAS NO DAMAGE ON THE INTERCONNECT CABLE. THE REP CONFIRMED THE CABLES ON THE BACK OF THE MONITOR WERE FULLY SEATED AND NOT DAMAGED. EVERYTHING IN SELF-TEST WAS CONNECTED AND GREEN. IT WAS NOTED THAT THE REP DID NOT SWAP INTERCONNECT CABLE, SSD, OR A MAIN CART WITH THE FAULTED CAMERA CART TO SEE IF ISSUE WOULD REPLICATE AS THE ISSUE WAS INTERMITTENT AND DID NOT REPLICATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576289 ↗
• MalfunctionMar 11, 2026Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571914 ↗
• MalfunctionMar 9, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT UPON BOOT UP, THE LOGIN PAGE APPEARED OFF CENTER ON THE RIGHT SIDE OF THE SCREEN. THE ISSUE PERSISTED ON BOTH THE SYSTEM'S MONITORS. THEY USED ANOTHER NAVIGATION SYSTEM FOR THE CASE. DURING TROUBLESHOOTING, TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING A HARD REBOOT. TS RECOMMENDED CONFIRMING MONITOR RESOLUTION AND ASPECT RATIO. THIS ISSUE CAUSED A LESS THAN 1 HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546391 ↗

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