StealthStation S8 Platform 9735668 (UDI 00763000359928)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000359928), received between Jan 18, 2022 and Dec 17, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Mechanical 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CABLE WAS DAMAGED ON THE BREAKOUT BOX (BOB). THE CABLE HAD EXPOSED WIRES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831820 ↗
• MalfunctionNov 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY OF 1-2MM. THIS WAS NOTICED WHEN THE SURGEON WENT TO PLACE THE BURR HOLE, AND TESTED ACCURACY USING THE STYLET. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF NAVIGATION, USING ANATOMICAL LANDMARKS. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THEY USED THE SYSTEM IN ANOTHER CASE AND HAD NO REPORTED ISSUES. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496762 ↗
• MalfunctionSep 2, 2025Display 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 DURING A PLANNED MAINTENANCE (PM), THE MANUFACTURER REPRESENTATIVE (REP) GRABBED THE MONITOR AND THE MONITOR SHUT OFF. HE RESEATED CABLES INTO THE BACK OF THE MONITOR WHICH RESOLVED THE ISSUE. HE WAS UNABLE TO REPLICATE THE SHUTOFF AFTER RESEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940524 ↗
• MalfunctionSep 2, 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 CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT IN A SHUNT PLACEMENT PROCEDURE THE SURGEON ULTIMATELY ABANDONED NAVIGATION DUE TO A PERCEIVED NAVIGATIONAL INACCURACY. PER THE MANUFACTURER REPRESENTATIVE (REP), REGISTRATION WAS NORMAL AND ACCURACY CHECKS LOOKED GOOD, BUT WHEN THE SURGEON WENT TO INSERT THE CATHETER, SHE NOTICED NAVIGATION WAS OFF. SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF NAVIGATION, USING ANATOMICAL LANDMARKS. REP ALSO REPORTED THAT THE SYSTEM WAS USED LATER FOR A SEPARATE PROCEDURE, AND THERE WERE NO REPORTED ISSUES. THE PROBABLE CAUSE WAS LIKELY A PATIENT REFERENCE FRAME SHIFT, AND USER ERROR. 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 22937726 ↗
• MalfunctionJul 9, 2025Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SITE HAD TO CONSISTENTLY REVERIFY THE NAVIGATION SYSTEM INSTRUMENTS IN ORDER FOR THEM TO SHOW UP. IT WAS NOTED THAT THE PROBABLE CAUSE OF THE ISSUE WAS A SUSPECTED INSTRUMENT TRACKER ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. THERE WAS LESS THAN AN HOUR OF SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461950 ↗
• MalfunctionMay 23, 2025Electrical /Electronic Property Problem; Mechanical Problem; Component Missing; Electrical /Electronic Property Problem; Mechanical Problem; Component Missing

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE UNPLUGGING THE ELECTROMAGNETIC NAVIGATION INTERFACE UNIT (AXIEM) BOX, THE END OF THE CABLE COVER SLID OFF. THE SILVER PORTION OF THE LEMO CONNECTOR WAS MISSING AND COMPLETELY OFF THE CABLE. THE AXIEM BOX WAS DAMAGED. THE SYSTEM WAS NO LONGER ABLE TO CONNECT TO THE PORT ON THE NAVIGATION SYSTEM. THE ELECTROMAGNETIC (EM) INTERFACE'S CABLE WAS MISSING THE LEMO CONNECTION AND HAD EXPOSED WIRES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079500 ↗
• MalfunctionJan 28, 2025Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS RESOLVED AFTER RESETTING THE COMPUTER CONNECTIONS, THE EQUIPMENT HAS WORKED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253752 ↗
• MalfunctionAug 7, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BREAK OUT BOX DID NOT POWER ON. THE BREAK OUT BOX WAS REBOOTED MULTIPLE TIMES, AFTER 4 OR 5 TIMES IT POWERED ON. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927669 ↗
• MalfunctionJan 19, 2024Excessive Heating; Excessive Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THERE WAS A BURNING SMELL WHEN POWERING THE SYSTEM ON UPON INITIAL INSTALL. NO PATIENT WAS PRESENT. ADDITIONAL INFORMATION WAS LATER RECEIVED. A MEDTRONIC REPRESENTATIVE (REP) CALLED BACK TO REPORT THAT THE ISSUE WAS STILL OCCURRING. THE BURNING SMELL WAS OVERPOWERING, THE REP REPORTED A BIOMED ON SITE DESCRIBED IT AS "ELECTRICAL", THE REP REPORTED IT WAS STRONGEST AT THE BACK OF THE UPS. THEY INSPECTED ALL CABLES PLUGGING INTO THE UPS, AND NONE HAD ANY VISIBLE MELTING OR CHARRING. THEY INSPECTED THE BATTERY PACK, AND THE BOTTOM HAD SOME VISIBLE BLACK MARKINGS AROUND THE EDGES OF THE BATTERIES AND THERE WAS SOME BLACK MARKING ON THE BOTTOM OF THE BATTERY TRAY THAT LINED UP WITH THE CHARRING ON THE BATTERY PACK. THEY DISCONNECTED THE BATTERY PACK, MOVED THE BATTERY PACK INTO A DIFFERENT ROOM, TURNED THE SYSTEM ON. THE SMELL COULD STILL BE DETECTED AND SEEMED LIKE IT WAS STILL COMING FROM THE BACK OF THE UPS. THE CHARRING COULD BE SEEN UNDER THE THUMB SCREW PLATE FOR THE: BATTERY TRAY, U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544615 ↗
• MalfunctionJul 12, 2023Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EMITTER SEEMED TO BE HAVING ISSUES. THE CORD TO THE EMITTER SEEMED TO HAVE PHYSICAL DAMAGE AS WELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306574 ↗
• MalfunctionFeb 27, 2023Human-Device Interface Problem; Application Program Freezes or Fails to Launch; Human-Device Interface Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT THE MOST LIKELY CAUSE OF THE ISSUE CAME FROM A FAULTY BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16445669 ↗
• MalfunctionFeb 7, 2022Material Integrity Problem; Material Integrity Problem

  (B)(6) 2021 SALESFORCE (B)(4) (REP): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD AN AMBER LIGHT ON THEIR INTERFACE BOX PORT 6.  WHEN OPENING THE TRACKING DETAILS, PORT 6 WAS LISTED AS FAULTED. THIS WAS NOTED DURING SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13473401 ↗
• MalfunctionJan 18, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT AFTER REGISTERING THE PATIENT AND FLIPPING THEM, AFTER OPENING THE SCALP THE NAVIGATION WAS OFF. THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE POTENTIAL OF PATIENT MOVEMENT RELATIVE TO THE PATIENT TRACKER WAS LOW AS IT WAS AN EIGHT MONTH OLD CHILD. TECHNICAL SERVICES (TS) RECOMMENDED THAT THE SITE RE-REGISTER AND INCLUDE MORE POSTERIOR POINTS. THERE WAS NO IMPACT ON PATIENT OUTCOME. THERE WAS NO SURGICAL DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281689 ↗

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