StealthStation S8 9735669 (UDI 00763000360504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000360504), received between Mar 15, 2022 and Mar 10, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 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 DURING A CASE, THEY SUCCESSFULLY REGISTERED WITH A REGISTRATION OF "ONE SOMETHING" AND WHEN THEY WENT INTO THE NAVIGATION SCREEN, "THE IMAGE WAS BLACK WITH ONLY THE TEETH SHOWING." THE SITE BROUGHT IN THEIR OTHER NAVIGATION SYSTEM TO CONTINUE WITH CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE DEGREE OF REGISTRATION INACCURACY WAS 1.4 MM AND SUSPECTED TO BE DUE TO USER ERROR. THERE WAS A SURGICAL DELAY REPORTED AS EITHER 8 OR 15 MINUTES (DEPENDENT ON THE RESPONDENT). A MANUFACTURER REPRESENTATIVE (REP) WAS UNABLE TO REPLICATE THE ISSUE OF "THE IMAGE WAS BLACK WITH ONLY THE TEETH SHOWING". HE SUSPECTED IT WAS A WINDOW LEVEL ISSUE, ALTHOUGH A DIFFERENT REP ATTRIBUTED THE ISSUE TO USER ERROR. THE SYSTEM FUNCTIONED PERFECTLY THROUGH SEVERAL REGISTRATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559262 ↗
• MalfunctionFeb 3, 2026Electrical /Electronic Property Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S POWER CABLE HAD A SMALL TEAR. AS A RESULT, THERE WAS EXPOSED WIRING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246080 ↗
• InjuryJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE SITE WAS UNABLE TO OBTAIN THE AMOUNT OF INACCURACY DUE TO THE TRACKING GOING IN AND OUT. THE PATIENT WAS NOTED TO HAVE BLURRED VISION AFTER THE SURGERY.

  Patient problems: Blurred Vision; Swelling/ Edema

  MAUDE report 24180831 ↗
• MalfunctionJun 20, 2025Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299130 ↗
• MalfunctionJun 5, 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 FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE INTERIOR/POSTERIOR WAS INACCURATE BY "OVER 2MM." THE ALLEGED INACCURACY WAS WITH DIFFERENT INSTRUMENTS AND THE PATIENT TRACKER DID NOT MOVE. IT WAS INDICATED THAT THE SURGERY WAS ABORTED. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152627 ↗
• MalfunctionJun 3, 2025Device Sensing 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 INSTRUMENT TRACKING BECAME INTERMITTENT WHEN NAVIGATING IN THE SINUS DURING AN ELECTROMAGNETIC (EM) PROCEDURE. TECHNICAL SERVICES (TS) RECOMMENDED REPOSITIONING THE FLAT EMITTER AND ENSURING THERE WAS NO METAL IN THE FIELD. THE SITE DID WHAT TS RECOMMENDED AND THE ISSUE WAS NO LONGER PRESENT. THERE WAS A DELAY OF LESS THAN ONE HOUT. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131989 ↗
• MalfunctionMay 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; 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 SITE WAS UNABLE TO PASS REGISTRATION DURING A FESS CASE. SITE WAS ATTEMPTING TOUCH REGISTRATION WITH 4 POINTS. REGISTRATION FAILED ACROSS MULTIPLE ATTEMPTS WITH NO REGISTRATION ACCURACY BEING SHOWN. AFTER 2 ATTEMPTS THE SITE WAS ABLE TO ACHIEVE SATISFACTORY REGISTRATION WITH A 1.3MM ACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090550 ↗
• MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem; Incorrect, Inadequate or Imprecise Result or Readings; 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 SITE WAS HAVING ISSUES REGISTERING. THEY WERE HAVING ISSUE REGISTERING. THEY RESTARTED AND WERE STILL HAVING ISSUES. THEY WERE USING PATIENT REFERENCE FRAME TO TRACE AND THE DOTS WERE SHOWING UP NOT ON THE PATIENT. TECHNICAL SERVICES (TS) CHANGED THEM TO THREE-POINT TOUCH. WHEN ATTEMPTING TO START WITH THE FIRST POINT OF THREE POINT TOUCH ERROR 64 OCCURRED. THE SYSTEM RESTARTED ON ITS OWN AND THEY WERE ABLE TO CONTINUE TRACING. REGISTRATION WAS SUCCESSFUL BUT THE DOCTOR WANTED A BIGGER GREEN CIRCLE OF ACCURACY. IT APPEARED LIKE THEY HAVE A FULL HEAD AVAILABLE ON THE 3D IMAGE BUT THE PATIENT IS DRAPED AND NOT ABLE TO TRACE THE TOP OF THE HEAD OR ADD TOUCHPOINTS TO THE EARS. ONLY THE FOREHEAD, NOSE AND EYES WERE AVAILABLE TO TRACE AND ADD TOUCHPOINTS TO. ADDING A TOUCHPOINTS ON THE INNER CAMPUS, OUTER CAMPUS, TIP OF NOSE AND TRACING A BIT MORE ON THE PATIENT HELPED. THE DOCTOR WAS RELYING ON THE REGISTRATION ACCURACY NUMBER INSTEAD OF VERIFYING ACCURACY. SOMETIMES ADDING OUTER EYE CAMPUS OF ONE OF THE EYES INCREASED THE REGIST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861786 ↗
• MalfunctionMar 17, 2025Display or Visual Feedback Problem; Application Program Problem; Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT 'NO VIDEO DETECTED' OCCURRED AN HOUR INTO A CASE. THE MANUFACTURER REPRESENTATIVE (REP) MOVED THE MONITOR AND THE MONITOR DISPLAYED 'NO VIDEO DETECTED.' DURING TROUBLESHOOTING, THE REP REBOOTED THE SYSTEM 3 TIMES AND RESEATED ALL OF THE CABLES IN THE BACK OF THE MONITOR. THE REP TRIED 2 OTHER WALL OUTLETS AND MOVED TO HALLWAY TO FURTHER TROUBLESHOOT. THE REP CHECKED THE SOFT KEYS - ISSUE UNRESOLVED. THE REP HARD REBOOTED AGAIN - ISSUE UNRESOLVED. THE REP USED A KNOWN WORKING HIGH-DEFINITION MULTIMEDIA INTERFACE(HDMI) CABLE AND PLUGGED IN STRAIGHT FROM THE COMPUTER DONGLE TO THE MONITOR. THE ISSUE WAS UNRESOLVED. THE MEDTRONIC NAVIGATION SYSTEM WAS ABORTED. 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 21621405 ↗
• MalfunctionFeb 7, 2025Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING REGISTRATION THEY ACQUIRED A 1.8 REGISTRATION ACCURACY; HOWEVER, THE ACCURACY WAS OFF AND SHOWING THE INSTRUMENT IN THE ANATOMY WHEN THE INSTRUMENT WAS ON THE SURFACE OF THE SKIN. THE HEALTHCARE PROVIDER (HCP) VERIFIED THE PATIENT TRACKERS WERE NOT FROM THE LIST OF LOT NUMBERING FAILING TO VERIFY. THE MEDTRONIC REPRESENTATIVE (REP) SWITCHED TO ANOTHER SCAN AND THE ACCURACY WAS AT 1.5 AND TRACKING CORRECTLY. THERE WAS LESS THAN ONE HOUR OF DELAY AND THIS HAD NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE REGISTRATION SEEMED TO BE EMBEDDED WITHIN THE PATIENT, WHICH EXPLAINS WHY THE NAVIGATION WAS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334236 ↗
• MalfunctionDec 4, 2024Display or Visual Feedback Problem; Power Problem; Unexpected Shutdown; Display or Visual Feedback Problem; Power Problem; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION, REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED, THAT THE MAIN CART MONITOR WAS FLICKERING. AND DURING TROUBLESHOOTING, IT WAS OBSERVED, THAT THE ERROR LIGHT ON THE UNINTERRUPTED POWER SOURCE (UPS) WAS LIT RED. ADDITIONALLY, THE BATTERY LIGHT DID NOT ILLUMINATE. DESPITE BEING CONNECTED. AND THE UNIT SHUT DOWN IMMEDIATELY, WHEN UNPLUGGED FROM WALL POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849152 ↗
• MalfunctionOct 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT PROBE AND STRAIGHT SUCTION WERE NOT TRACKING ACCURATELY. THERE WAS NO REPORTED DELAY TO PROCEDURE AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453000 ↗
• MalfunctionSep 5, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BREAK OUT BOX (BOB) CORD THAT WAS CLOSER TO THE BOB WAS NO LONGER CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152006 ↗
• MalfunctionDec 28, 2023Application 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 THIS SYSTEM BECAME UNRESPONSIVE DURING A CASE. THIS OCCURRED ONCE THE STAFF REACHED THE REGISTRATION PAGE. THE EVENT CAUSED A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME. TROUBLESHOOTING INFORMATION WAS PROVIDED. THE SITE REBOOTED THE SYSTEM AND THE SYSTEM DID NOT BECOME UNRESPONSIVE AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410955 ↗
• MalfunctionAug 15, 2023Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A THYROIDECTOMY. IT WAS REPORTED THAT WHEN STARTING REGISTRATION, THE 3D MODEL DISAPPEARED FROM THE SCREEN AND REPOPULATE WHILE SURGEON WAS TALKING TO THE REPRESENTATIVE ON THE PHONE A FEW MINUTES LATER. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED A LESS THAN 1 HOUR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550459 ↗
• MalfunctionMar 15, 2022Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  ON (B)(6) 2022, (B)(4) (HCP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE FACILITY HAD DIFFICULTIES WITH NAVIGATION. THE FACILITY NOTED THAT THE ISSUE OCCURRED SEVERAL TIMES, HOWEVER NO CLARIFICATION OF DATES AND TIMES OF PREVIOUS OCCURRENCES WAS PROVIDED BY THE FACILITY WHEN REPORTED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. ADDITIONAL INFORMATION WAS PROVIDED REGARDING A RECENT CASE. AFTER PERFORMING A SUCCESSFUL REGISTRATION AND VERIFYING SURFACE ANATOMY, THE INTERNAL ANATOMY WAS OFF BY APPROXIMATELY 1CM OR MORE. THE PROBABLE CAUSE WAS REPORTED TO BE MOVEMENT OF THE PATIENT REFERENCE DURING SURGERY. IT WAS NOTED THE NEW PATIENT REFERENCES HAD A SMALL GAP NEAR THE SKIN AT THE DIVOT AREA. ONCE THE PATIENT REFERENCE WAS VERIFIED, IT WAS STABLE AND CLOSE TO THE PATIENT'S HEAD. WHEN PLACING THE REFERENCE ON THE MOST FLAT PART OF THE PATIENT'S FOREHEAD FOR IMPROVED RESULTS. THE SURGEON WAS INFORMED TO BE CAUTIOUS TO NOT PRESS ON THE PATIENT REFERENCE WHEN PERFORMING VERIFICATION OF INSTRUMENTS. NEXT ACTIONS WOULD INCLUDE A SYSTEM CHECKOUT AND ONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765443 ↗

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