StealthStation S8 Platform 9735665 (UDI 00643169722187)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,668 adverse event reports that list this exact device (DI 00643169722187), received between May 23, 2017 and Sep 25, 2026 — classified as 4 deaths, 94 injuries, 4,570 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (871 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 4,668 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 50902140 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Medtronic received information regarding a navigation system being used intra-operatively during a cervical spine procedure. It was reported that the site felt they were 5mm off (inferior) after the spin. They swapped the frame clamp it was still off by 5mm (inferior) even after re-spinning with a new clamp. As they worked towards the frame they found that accuracy improved, but was never perfect. There was a less than one hour surgical delay and no impact on patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899891 ↗
• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891873 ↗
• MalfunctionSep 14, 2026Electrical /Electronic Property Problem; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756822 ↗
• MalfunctionSep 14, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756299 ↗
• MalfunctionSep 10, 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 during a spinal fusion T3-pelvis, T3-T9 image was taken and sent to the navigation system. The screws were placed on the right side. The surgeon did not report any inaccuracy in placing these screws. When moving to top of construct for the left screws, surgeon reported inaccuracy in screw location. Surgeon aborted use of navigation for remainder of procedure. There was a delay of less than 1 hour in the length of the procedure. There was no impact on patient outcome.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716396 ↗
• MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697513 ↗
• MalfunctionSep 4, 2026Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619062 ↗
• MalfunctionAug 31, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526787 ↗
• MalfunctionAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326100 ↗
• MalfunctionAug 6, 2026Use of Device Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160275 ↗
• MalfunctionJun 22, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED TO REQUEST A QUOTE TO REPLACE SEVERAL PARTS ON THE SYSTEM, SOME BECAUSE OF DAMAGE AND SOME BECAUSE THEY WERE KNOWN THIRD-PARTY PARTS, TO PREPARE THE SYSTEM FOR A PLANNED MAINTENANCE (PM). THE THIRD-PARTY PARTS WERE THE MAIN CART BATTERY AND THE CAMERA CART BATTERY. THE DAMAGED MEDTRONIC PARTS WERE THE ALTERNATING CABLE (AC) POWER CORD, DUAL USB PORT, CAMERA ETHERNET CABLE, MAIN CART MONITOR, AND STORAGE BIN. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587854 ↗
• MalfunctionJun 10, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A VENTRICULOPERITONEAL (VP) SHUNT PROCEDURE. THE FOLLOWING ISSUES OCCURRED. IT WAS REPORTED THAT THE CAMERA CART SHUT DOWN WHEN UNPLUGGED FROM WALL POWER WHILE MAIN CART STAYED ON. SELF-TEST SHOWED 100% WHEN CONNECTED TO WALL POWER. THERE WERE EXPOSED WIRES ON PART OF THE CABLE. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458332 ↗
• MalfunctionJun 9, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CABLE CONNECTOR ON THE INSTRUMENT INTERFACE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ONE OF THE STAFF PULLED OUT THE INSTRUMENT INTERFACE CONNECTOR AND THE CONNECTOR BROKEN IN HALF IN THEIR HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448368 ↗
• MalfunctionJun 8, 2026Mechanical Problem; Naturally Worn

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAS A DAMAGED BREAKOUT BOX (BOB) CABLE. DUE TO WEAR AND TEAR. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438290 ↗
• MalfunctionMay 19, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INTERCONNECT CABLE WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225146 ↗
• MalfunctionMay 19, 2026Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS EXPERIENCING ISSUES WITH THEIR FLAT EMITTER. THE SITE STATED THAT WHEN THE FLAT EMITTER WAS PLUGGED INTO THE SYSTEM, IT WOULD DISPLAY "LOCALIZER FAULTED." WHEN THE MEDTRONIC REPRESENTATIVE (REP) GOT TO THE SITE, HE WAS ABLE TO VERIFY THIS AND FOUND THAT WHEN USING THE SITE'S SIDE EMITTER, THE MESSAGE WENT AWAY. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES HAD THE REP CHECK THE "PRINT CAMERA DIAGNOSTICS" UTILITY AND FOUND THAT THE FLAT EMITTER WAS FAULTED AND THE CONNECTIONS ON THE FLAT EMITTER HAD GONE BAD. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT TECHNICAL SERVICES (TS) HAD THE CLINICAL SPECIALIST (CS) CHECK THE "PRINT CAMERA DIAGNOSTICS" UTILITY AND FOUND THE FLAT EMITTER WAS REPORTED AS FAULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219453 ↗
• MalfunctionMay 14, 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 THE 4.5 TAP HAD AN ALLEGED INACCURACY. THEY USED ANOTHER TAP WITH THE SAME NAVLOCK, AND IT WORKED WITH NO REPORTED ISSUES. NO ADDITIONAL INFORMATION PROVIDED AT THE TIME OF CALL. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173234 ↗
• MalfunctionMay 13, 2026Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN PREPPING FOR AN EM CASE, THE SYSTEM STARTED REPORTING "LOCALIZER FAULTED." THE MANUFACTURER REPRESENTATIVE (REP) SWITCHED OUT THE EMITTER, BUT THE ISSUE DID NOT RESOLVE. THE REP THEN SWAPPED OUT THE EMITTER BREAKOUT BOX (BOB) AND THE LOCALIZER FAULTED MESSAGE WENT AWAY. TECHNICAL SERVICES (TS) HAD THE REP RUN THE PRINTCAMERADIAGNOSTICS TO DIAGNOSE THE ISSUE WITH THE BOB. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165175 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SYSTEM WAS UNPLUGGED FROM THE WALL, THE CAMERA CART SHUT OFF IMMEDIATELY, SELF-TEST REPORTED 100% CHARGED. THE POWER CABLE GREY PORTION WAS SLIPPING AND THE CORDS INSIDE WERE EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113237 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FOOTSWITCH HAD MISSING PLASTIC AND EXPOSED WIRES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113066 ↗
• MalfunctionMay 4, 2026Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE ARTICULATING ARM SHIFTED AFTER REGISTRATION. THE SURGEON RE-DRAPED AND SWITCHED TO ELECTROMAGNETIC (EM) NAVIGATION. THERE WAS A LESS THAN ONE HOUR DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069713 ↗
• MalfunctionMay 4, 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 WAS FLASHING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067671 ↗
• MalfunctionApr 20, 2026Electrical /Electronic Property Problem; Mechanical Problem; Naturally Worn

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE REPLACING THE MONITOR FOR A RELATED CASE, THE MEDTRONIC REPRESENTATIVE FOUND THAT THE UMBILICAL CORD WAS FRAYED AND THE INTERNAL WIRES WERE EXPOSED. ADDITIONALLY, THE POWER CORD HAD SEVERAL LARGE SCUFFS AND WEAR MARKS. THESE CORDS HAVE NEVER BEEN REPLACED IN THIS SYSTEM'S HISTORY. TECHNICAL SERVICES BELIEVED THIS WAS DUE TO NORMAL WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932211 ↗
• MalfunctionApr 17, 2026Display or Visual Feedback Problem; Failure to Power Up; Application Program Problem; Failure to Shut Off

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CLINICAL SPECIALIST (CS) WAS RECEIVING A NO VIDEO DETECTED ON MAIN CART. WHEN THE CS PLUGGED IN THE CAMERA CART, IT WAS UNABLE TO TURN ON. THE CS ATTEMPTED TO POWER OFF THE MAIN CART BUT UNABLE TO SHUT OFF THE BLUE POWER BUTTON FULLY OFF. DURING TROUBLESHOOTING, THE CS ATTEMPTED TO HARD REBOOT THE SYSTEM WITH NO RESOLUTION AS THE CAMERA CART WOULD NOT POWER ON AND THE MAIN CART WOULD NOT POWER DOWN FULLY. THE CS DISCONNECTED THE BATTERY FROM THE SYSTEM AND THE MAIN CART FINALLY SHUT OFF. UPON REBOOTING, THE CS COULD HEAR FANS FROM THE MAIN CART. UPON PRESSING THE MAIN CART POWER BUTTON, THE MAIN CART WOULD NOT TURN ON BUT THE CAMERA CART TURNED ON. AFTER PRESSING AGAIN, BOTH CARTS WERE NOW POWERED ON TO THE LOG IN SCREEN. THE CAMERA CART EVENTUALLY CONNECTED AFTER SHOWING "CONTACTING IT" SCREEN FOR 30 SECONDS. THE CS HARD REBOOTED AND POWERED ON THE SYSTEM ONE MORE TIME TO ENSURE ISSUE COULD NOT BE RECREATED WHICH WAS TR UE. THE SYSTEM WAS NOW FUNCTIONING AS INTENDED AND THEY COULD NOT REPLICATE THE NO VIDEO DETECTED ISSUE AFTER RESETTING POWER AND COMMUNICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911469 ↗

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