StealthStation S8 9735669 (UDI 00763000360498)Recalls & reported problems

Summary

The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 00763000360498), received between Nov 4, 2021 and Sep 15, 2026 — classified as 2 injuries, 357 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (101 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 359 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778937 ↗
• MalfunctionAug 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459724 ↗
• MalfunctionJun 25, 2026Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRIOR TO A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SYSTEM WAS INTERMITTENTLY DISPLAYING A LOCALIZER FAULT. THIS FIRST OCCURRED ON (B)(6) 2026 WHEN A PATIENT WAS NOT PRESENT. THE MESSAGE RESOLVED ITSELF SOON AFTER DISPLAYING. THIS OCCURRED WITH THE SITE'S ONLY FLAT EMITTER. TROUBLESHOOTING WAS PERFORMED. THE MEDTRONIC REPRESENTATIVE (REP) RAN PRINTCAMERA DIAGNOSTICS-, THERE WAS NO FAULT THE 1ST TIME, RESULTS WHEN THE LOCALIZER FAULT MESSAGE APPEARED: STATUS: FAULTED AMPLIFIERS ENABLED: TRUE CONTROLLER: FAULTED TCA: FAULTED SYSTEM FAULTS: TRANSMIT COIL 3, 4, 5, 10. (SAME AS PREVIOUS CASE, CONTROLLER REPLACED, NO CONTROLLER FAULTS FOUND IN ANALYSIS). THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INTERMITTENT LOCALIZER FAULT MESSAGES WERE APPEARING WHEN MOVING THE F LAT EMITTER FROM THE BIN TO THE TABLE. THE MESSAGE CLEARED WHEN THE REP PUT IT ON THE TABLE. TECHNICAL SERVICES (TS) TOLD REP THAT THE BEHAVIOR WAS IN LINE WITH ANOTHER CASE. AS ISSUE DOES NOT OCCUR WHILE ON THE TABLE, TS INFORMED REP TO COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622481 ↗
• MalfunctionJun 17, 2026Electrical /Electronic Property Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538827 ↗
• MalfunctionMay 13, 2026Incorrect Interpretation of Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD TROUBLE VERIFYING AND TRACKING THE 90 DEGREE CURVED SUCTION AND STRAIGHT SUCTION. IT WAS NOTED THAT THEY DISPLAYED RED WITH ~3.5 GEOMETRY ERROR. THERE WERE NO ISSUES WITH VERIFYING THE REGISTRATION PROBE NOR REGISTERING THE PATIENT. THERE WERE NO ISSUES WITH PATIENT TRACKER. IT WAS NOTED THAT THE ISSUE WAS CONSISTENT ACROSS THE WHOLE FLAT EMITTER. THE MANUFACTURING REPRESENTATIVE (REP) CONFIRMED THAT THERE WAS NO APPARENT METAL INTERFERENCE, THE PATIENT'S HEAD MAY HAVE FILLED THE EM VOLUME MORE THAN TYPICAL BUT NO SIGNIFICANT DISTANCE BETWEEN HEAD AND EMITTER, ALL BOB PORTS SHOWED GREEN WHEN CONNECTED TO INSTRUMENT TRACKER, AND THEY HAD SWAPPED INSTRUMENT TRACKERS. IT WAS NOTED THAT THE REP DID NOT HAVE DEMO HEAD, OR NOR OWN INSTRUMENTS TO FURTHER TROUBLESHOOT WITH. FURTHER TROUBLESHOOTING WAS PERFORMED. THE PORT STATUSES WERE ALL GREEN WHEN CONNECTED WITH A TRACKER. THEY WERE UNABLE TO REPLICATE COMPLAINT WITH ORIGINAL INSTRUMENTS AND DEMO MODEL. GEOMETRY ERRORS: - NIPT: 0.38 - STRAIGHT SUCTION :1.7 - 90-DEGREE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161443 ↗
• MalfunctionApr 1, 2026Mechanical Problem; Application Program Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED 'LOCALIZER FAULTED' IN THE EAR, NOSE, & THROAT (ENT) ELECTROMAGNETIC (EM) SOFTWARE AFTER ATTEMPTING TO FURTHER TROUBLESHOOT WITH THIS SYSTEM AND PLUGGING IN BREAK OUT BOX FROM ANOTHER NAVIGATION SYSTEM. DURING TROUBLESHOOTING, THE CLINICAL SPECIALIST (CS) REPORTED THE BREAKOUT BOX HAD A FAULT LIGHT ON IT AND NO LIGHTS ON ANY PORTS. THE CS REPORTED AFTER FURTHER TROUBLESHOOTING, THE BREAKOUT BOX FROM ANOTHER NAVIGATION SYSTEM WAS PLUGGED INTO THIS SYSTEM AND DISPLAYED 'LOCALIZER FAULTED.' THE CS WENT INTO PRINT CAMERA DIAGNOSTICS AND REPORTED THAT THE CONTROLLER WAS FAULTED AND THE SYSTEM FAULTS: "RTCODE". THE CS COULD NOT CONFIRM WHICH BREAK OUT BOX DETERMINED THE ISSUE OF SHORTING THE CONTROLLER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757595 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE ACCURACY DRIFTED THROUGHOUT CASES, 3-POINT TOUCH HELPED IMPROVE REGISTRATION, AND THEY PROVIDED GUIDANCE REGARDING THE DENTAL SCANNER USED BY THE SITE AND THE NAVIGATION/SYNERGY IMAGING PROTOCOL. IT NOTED THE DAY BEFORE THAT THERE WAS A 0.8 ACCURACY AT REGISTRATION. THE ACCURACY WORSENED WHEN NAVIGATING FURTHER INTO THE SINUS-- APPEARED THAT THE SURGEON WAS NAVIGATING IN THE MOUTH. THE FLAT EMITTER WAS BEING USED AND THE PATIENT HAD METAL IN TEETH/JAW, THE IMAGE HAD AN ARTIFACT, REPEATEDLY SEEN WITH THIS SCANNER-- NAVIGATION IMAGE MODIFICATION WOULD REMOVE TOO MUCH OF THE PATIENT FOR NAVIGATION, THE IMAGE DID NOT INCLUDE BACK OF THE HEAD FULLY, BUT INCLUDED THE SINUSES, AND THE TRACE PATTERN DID NOT MIMIC "CHRISTMAS TREE" UP THE NOSE. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742550 ↗
• MalfunctionMar 30, 2026Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  TROUBLESHOOTING WAS PERFORMED. A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT PRESSING THE FOURTH SOFTKEY WAS CYCLING THROUGH THE INPUT OPTIONS AND PRESSING THE FIFTH SOFTKEY BUTTON TURNED THE MONITOR OFF/ON. TECHNICAL SERVICES (TS) HAD THE REP OPEN THE SOFTKEY MENU AND CHECK STATUS OF SOFTKEY MENU LOCK. THEY FOUND THAT SOFTKEY MENU LOCK WAS ON. THEY CHANGED LOCK TO OFF THEN BACK TO ON BUT THE FOURTH/FIFTH SOFTKEY BUTTONS STILL REACTED. A REP NOTED THAT WHEN ATTEMPTING TO CHECK THE SOURCE INPUT THROUGH THE SOFTKEYS, THE DISPLAY WENT "BLACK." THE DISPLAY CYCLED THROUGH THE SPLASH SCREEN, BLACK SCREEN, AND "NO SIGNAL" AND "DP" DISPLAY WHEN TAPPING ANY OF THE SOFTKEYS. THE POWER CYCLED THE SYSTEM, UNPLUGGING AND HOLDING DOWN THE POWER BUTTON BEFORE BOOTING SYSTEM BACK UP. THE MONITOR POWER LIGHT WAS CONFIRMED TO ILLUMINATE BETWEEN GREEN THEN AMBER, WHEN THE DISPLAYED THE "NO SIGNAL," "DP," AND SPLASH SCREEN AND WENT BLACK, RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713892 ↗
• MalfunctionMar 20, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY TRACKING BOTH THE PATIENT TRACKER AND THE INSTRUMENT TRACKER. THE SITE SWAPPED OUT INSTRUMENT TRACKERS, PATIENT TRACKERS, AND THE EMITTER, BUT THE ISSUE PERSISTED. AS A RESULT, THE USE OF THE NAVIGATION SYSTEM WAS ABORTED FOR SURGERY. IT WAS UNKNOWN IF THERE WAS ANY EXTENDED SURGICAL TIME OR IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650014 ↗
• MalfunctionMar 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER DOWNLOADING THE PATIENT'S COMPUTED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE (MR) IMAGES WIRELESSLY, WHEN THE IMAGES WERE OPENED, THE ANATOMY IN BOTH THE CT AND MR IMAGES APPEARED FLIPPED. FOR EXAMPLE, THE ANATOMY WAS SHOWN ON THE PATIENT¿S RIGHT SIDE WHEN IT SHOULD HAVE BEEN ON THE LEFT. A MANUFACTURER REPRESENTATIVE (REP) OVER VIDEO CONFERENCING WALKED THE SITE THROUGH MIRRORING THE IMAGES AND FLIPPING THE ORIENTATION, BUT THIS DID NOT RESOLVE THE ISSUE. EVENTUALLY, THE SITE BROUGHT IN A DIFFERENT MODEL OF NAVIGATION SYSTEM AND DOWNLOADED THE SAME SET OF IMAGES WIRELESSLY; BOTH THE CT AND MR DISPLAYED CORRECTLY ON THAT SYSTEM. THE SITE DID NOT RELOAD THE PATIENT SCANS ON THE INITIAL NAVIGATION SYSTEM. THE REP CONFIRMED THAT HE WAS ONLY ABLE TO VISUALLY VERIFY THAT THE CT ORIENTATION WAS FLIPPED; HE WAS UNABLE TO CONFIRM THE MR ORIENTATION HIMSELF, BUT THE SITE STATED THAT THE MR SHOWED THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE TROUBLESHOOTING LASTED AROUND 25 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577946 ↗
• MalfunctionMar 9, 2026No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY REGISTERING THE PATIENT. ALL TRACE POINTS ON THE NOSE WERE FOUND TO BE UNDER THE SKIN, RESULTING IN REGISTRATION INACCURACY. MULTIPLE TOUCH POINTS AROUND THE NOSE WERE ATTEMPTED, BUT NONE COULD BE SUCCESSFULLY REGISTERED. TROUBLESHOOTING WAS PERFORMED. THREE-POINT TOUCH METHOD WAS PERFORMED. HOWEVER, THE FIRST POINT AT THE TIP OF THE NOSE COULD NOT BE VERIFIED, PREVENTING FURTHER ATTEMPTS WITH THE THREE-POINT TOUCH METHOD. SWITCHING TO PATIENT REFERENCE FRAME REGISTRATION DID NOT RESOLVE THE ISSUE, AS TRACE POINTS REMAINED INACCURATE. MEDTRONIC IMAGING AND NAVIGATION WERE BOTH ABORTED, AND THE SURGEON ABANDONED USE OF THE SYSTEM SHORTLY AFTER. IT WAS NOTED THAT THE MODEL WAS MISSING ANATOMICAL FEATURES, SPECIFICALLY THE TOP OF THE FOREHEAD AND BOTH EARS, AND EXHIBITED INACCURATE SPACING AND THICKNESS, WHICH WAS VIEWED AS NON-OPTIMAL FOR STEALTH NAVIGATION. THERE WAS LESS THAN AN HOUR DELAY, AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553139 ↗
• MalfunctionMar 3, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS NOT TRACKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496799 ↗
• MalfunctionFeb 27, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  (B)(6) 2025 00852496 (REP, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THAT DURING A CASE, THE SCREEN ON THE NAVIGATION PAGE WENT UNRESPONSIVE AND DISPLAYING A LOW PERFORMANCE ERROR. A MANUFACTURER REPRESENTATIVE (REP) NOTED THAT THEY WERE ABLE TO PERFORM REGISTRATION SUCCESSFULLY. THEY ADDED THAT THE SITE TRIED REBOOTING THE SYSTEM AND CHANGING POWER OUTLETS FOR THE SYSTEM WHEN HE WAS TROUBLESHOOTING ON CALL WITH THE SITE. THE PROCEDURE WAS ABORTED. THERE WAS A 45 MINUTE DELAY. IT WAS SUSPECTED THAT THE ERROR WAS ASSOCIATED WITH LOW MEMORY STORAGE ON THE SYSTEM. IT WAS REPORTED THAT THE EVENT OCCURRED INTRA-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS CLARIFIED THAT THE PROCEDURE WAS NOT ABORTED. THE IMAGING WAS ABORTED. THE PATIENT WAS AFFECTED DURING THE CASE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED AS BOARDED. THE PROCEDURE WAS DELAYED FOR 5 - 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474701 ↗
• MalfunctionFeb 27, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SCREEN WENT BLACK DURING NAVIGATION, AND THEN THE SCREEN WENT BACK TO DISPLAYING AS EXPECTED. THE SITE CONTINUED WITH THE CASE. FURTHER INTO THE CASE, THE ISSUE REOCCURRED AND THEN THE SCREEN DISPLAYED AS EXPECTED AGAIN. THE SITE FINISHED THE CASE USING THE SYSTEM. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE SITE DID NOT REBOOT THE SYSTEM WHEN THE ISSUES OCCURRED. THIS ISSUE CAUSED A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472094 ↗
• MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY USING FIDUCIAL POINTS ON THE PATIENT. THE SURGEON WOULD MANUALLY CREATE THE FIDUCIAL POINT, BUT THEN IT WOULD MOVE UNDERNEATH THE SKIN WHENEVER THE PATIENT MODEL WAS TOUCHED IN THE SOFTWARE. NONE OF THE FIDUCIALS APPEARED TO SAVE THEIR LOCATION AND WERE SUBJECT TO MOVEMENT WHENEVER TOUCHED. TROUBLESHOOTING WAS PERFORMED, IT WAS STATED THAT THE PATIENT EXAM WAS NOT OPTIMAL FOR THE SYSTEM, AND ATTRIBUTED THAT TO BE PART OF THE REASON. 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 24433342 ↗
• MalfunctionFeb 24, 2026Display or Visual Feedback Problem; Unintended Application Program Shut Down

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR INTERMITTENTLY GOES BLACK. WHEN USER DISCONNECTED THE MONITOR POWER FROM THE MONITOR AND RECONNECTED IT, THE IMAGE GOES BACK TO WHERE IN THE APPLICATION IT WAS PREVIOUSLY. TROUBLESHOOTING WAS PERFORMED, THE SYSTEM REMAINED POWERED ON, AND THAT THE COMPUTER REMAINED UNAFFECTED BY THIS. SITE TRIED UNPLUGGING HDMI OR USB FROM THE BACK OF THE MONITOR, THIS DID NOT CHANGE THE SITUATION. UNPLUGGING POWER WAS THE ONLY THING THAT TEMPORARILY RESTORES FUNCTIONALITY TO THE MONITOR. NO OTHER SYSTEMS AVAILABLE AT THE ACCOUNT. THE PROBABLE CAUSE WAS EITHER FAULT WITH MONITOR OR UPS, BUT UNABLE TO DETERMINE EXACTLY WHICH PART THAT CAUSED THIS ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430312 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED A LOCALIZER FAULTED MESSAGE WHEN USING THE FLAT EMITTER. THE SITE REBOOTED THE SYSTEM WITH A FULL POWER CYCLE AND THE ISSUE RESOLVED. THERE WAS NO DELAY IN THE LENGTH OF THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME. ON 2026-JAN-23 IUD (REP): ADDITIONAL INFORMATION WAS RECEIVED. DURING TROUBLESHOOTING, THE MEDTRONIC REPRESENTATIVE (REP) WAS UNABLE TO DUPLICATE ISSUE WITH BOTH SIDE AND FLAT EMITTERS. PRINTCAMERADIAGNOSTICS SHOWED ALL COMPONENT STATUSES AS CONNECTED. ON 2026-JAN-29 IUD (REP): ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CORD ON THE BACK WASBENT AND IT FELL IN A FLAT POSITION, SO IT STAYED IN ONE POSITION. ON 2026-FEB-02 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED. THE CORRECT DATE OF THE EVENT WAS 2026-JAN-21.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338099 ↗
• MalfunctionFeb 9, 2026Failure to Power Up; Output Problem; Unexpected Shutdown; Excessive Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE UPLOADING IMAGES FROM A DISC, THE SYSTEM SHUT DOWN, AND THEY WERE UNABLE TO POWER IT BACK ON. THE MANUFACTURING REPRESENTATIVE (REP) REPORTED AN ELECTRIC BURNING SMELL WHEN ATTEMPTING TO POWER IT ON. IT WAS REPORTED BY THE REP NO LEDS WERE PRESENT ON THE UNINTERRUPTIBLE POWER SUPPLY (UPS), THE EXTERNAL AND INTERNAL POWER CABLE WAS CONNECTED AND HAD NO DAMAGE, THERE WAS NO LEAKAGE ON THE BATTERY, THE BATTERY DID NOT FEEL LIKE IT WAS OVERHEATING, AND AFTER DISCONNECTING THE BATTERY FROM THE UPS, THE SYSTEM DID NOT BOOT UP. BIOMED CHECKED THE FUSES AND THERE WAS NO REPORTED ISSUE. THE REP AND BIOMED BELIEVED THE BURNING SMELL WAS COMING FROM THE UPS. THE REP UNPLUGGED EVERYTHING FROM THE UPS BESIDES THE AC AND POWER BUTTON AND THERE WERE STILL NO LEDS VISIBLE ON THE UPS AFTER TRYING TO BOOT IT UP. IT WAS NOTED THAT THE PROBABLE CAUSE WAS THE WAS THE UPS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293115 ↗
• InjuryFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THERE WAS A NAVIGATION SYSTEM ACCURACY ISSUE. DURING SINUS SURGERY, THE SURGEON PENETRATED THE SKULL BASE IN THE POSTERIOR ETHMOID ON THE LEFT SIDE. THERE WAS A CSF (CEREBROSPINAL FLUID) LEAK, WHICH WAS DETECTED IMMEDIATELY. CONSULTED WITH A NEUROSURGEON. CLOSED THE CSF LEAK WITH SEVERAL LAYERS OF TACHOSIL, THEN MUCOSA, TISSEL GLUE, AND MUCOSA AGAIN. THERE WAS A MISMATCH BETWEEN THE NAVIGATION SYSTEM AND THE ACTUAL POSITION IN THE ETHMOID. FURTHER PATIENT IMPACT NOT PROVIDED. SURGICAL DELAY NOT PROVIDED. THE MANUFACTURER NAVIGATION AND IMAGING WERE ABORTED. THE SURGERY WAS ABORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24291287 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT WHEN VERIFYING ACCURACY, THEY WERE OFF BY .8MM TO .9MM ( TECHNICALLY WITHIN RANGE) AND THE REGISTRATION LINES WERE NOT MATCHING UP PROPERLY. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES (TS) CHANGED THEM OVER TO THREE POINT TOUCH AND THEY WERE ABLE TO REACH A SATISFACTORY TRACE. THERE WAS NO IMPACT ON PATIENT OUTCOME AND LESS THAN AN HOUR OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199094 ↗
• MalfunctionJan 27, 2026No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION AS RECEIVED. IT WAS REPORTED WHEN THEY FINISHED REGISTRATION, THE POINTS WERE NOT IN THE CORRECT AREA AND THE REGISTRATION FAILED AND STATED THAT TOO MANY POINTS WERE UNDER THE SKIN. TECHNICAL SERVICES (TS) WALKED THEM THROUGH THE THREE POINT TOUCH AND TOLD THEM TO DO A LIGHTER TOUCH AND THEY WERE ABLE TO PASS REGISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189372 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE MEDTRONIC REPRESENTATIVE (REP) NOTES THE ISSUE WAS LIKELY CAUSED BY BAD CT SCANS AND USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180541 ↗
• MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CC WAS ABLE TO FIND THE SETTING THAT CAUSED NAVIGATION TO SWITCH FROM TIP OF INSTRUMENT TO TIP OF PROJECTION. CC CHANGED SETTING BACK TO NAVIGATION FROM TIP OF INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178589 ↗
• MalfunctionJan 23, 2026Use of Device Problem; Application Program Problem; Device 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 HAD A SECOND OCCURRENCE OF A LOW PERFORMANCE ERROR MESSAGE. THE SITE REBOOTED THE SYSTEM AND DID NOT SEE THE ERROR MESSAGE. THIS ISSUE CAUSED AN EIGHT-MINUTE SURGICAL DELAY. THERE WAS NO IMPACT ON THE PATIENT¿S OUTCOME. IT WAS REPORTED THAT THE ERROR MESSAGE APPEARED DURING NAVIGATION. ONE, STRAIGHT SUCTION INSTRUMENT WAS IN THE FIELD OF VIEW. ONLY ONE COMPUTER TOMOGRAPHY (CT) EXAM WAS LOADED. THERE WERE NO MODELS, NO ANNOTATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164226 ↗
• MalfunctionJan 21, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THERE WAS A NAVIGATION INACCURACY. ACCORDING TO THE SURGEON, THE INITIAL NAVIGATION ACCURACY WAS CONFIRMED AT 1.4 MM; HOWEVER, AS THE SURGERY PROGRESSED, THE NAVIGATION BECAME INCREASINGLY INACCURATE, WITH DISCREPANCIES REACHING UP TO 5 MM NEAR THE SKULL BASE. ULTIMATELY, A CSF LEAK OCCURRED, AND NAVIGATION WAS ABORTED TO ADDRESS THE ISSUE. IT WAS ALSO NOTED THAT THE SCAN USED WAS AXIAL AND WAS TAKEN APPROXIMATELY 9¿10 MONTHS AGO (IN (B)(6) 2025). IT WAS REPORTED THAT DURING A CONVERSATION WITH THE SURGEON, THEY STATED THAT THE PATIENT THEY INITIALLY PULLED UP WAS NOT THE CORRECT PATIENT, EVEN THOUGH THEY HAD PREVIOUSLY IDENTIFIED THAT INDIVIDUAL AS THE PATIENT IN QUESTION. THE DOCTOR THEN PRESENTED ANOTHER PATIENT, CLAIMING THAT THE ISSUE WAS ASSOCIATED WITH THIS INDIVIDUAL; HOWEVER, THERE WAS NO PREVIOUS TRACE EVER SAVED TO THE UNIT FOR THAT PATIENT. IT WAS NOTED THAT IT IS UNCLEAR WHICH PATIENT EXPERIENCED THE INACCURACY, AND NO PATIENT ARCHIVE CAN BE PULLED. ALL SYSTEM CHECKOUT TESTS HAD PASSED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24132672 ↗

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