Stealthstation® S7™ 9733856RRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00613994603678), received between Oct 4, 2016 and Oct 4, 2023 — classified as 4 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Imprecision” (7 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS FLASHING AN AMBER LED AND TWO SOLID GREEN LIGHTS ON THE CAMERA AFTER POWERING ON. THE SYSTEM WAS REBOOTED AND THE ISSUE PERSISTED. THE SYSTEM WAS UNABLE TO ACTIVELY TRACK WITH THE CAMERA. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) INDICATING THAT THERE WAS A BUMP DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871173 ↗
• MalfunctionMay 26, 2022Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THEY WERE PLANNING FOR A CASE AND THE SYSTEM SHUT OFF. THEY FOUND THAT THE PLUG WAS LOOSE IN THE SOCKET SO WERE SUSPECTING THAT IT HAD LOST POWER, BUT THEY DID NOT HEAR ANY BEEPING. THEY DID NOT NOTICE IF THE LIGHT WAS FLASHING. THEY WERE ABLE TO REBOOT AND PROCEED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517627 ↗
• MalfunctionMar 24, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA LIGHT WAS AMBER NEXT TO THE GREEN POWER LIGHT. THERE WAS NO PATIENT INVOLVED. IT WAS NOTED THAT THE SITE TRIED TO TROUBLESHOOT BY REBOOTING THE SYSTEM MULTIPLE TIMES. THE SITE DID NOT CHECK THE NETWORK DETECTION AND RESPONSE (NDR) TOOLBOX BUT THE PROBABLE CAUSE WAS MOST LIKELY DUE TO A BROKEN CAMERA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895684 ↗
• MalfunctionMar 14, 2022Material Integrity Problem; Application Program Freezes or Fails to Launch; Material Integrity Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER CHANGING THE INPUT / OUTPUT (I/O) PANEL DURING A DIFFERENT CASE ON THE SITE, A SYSTEM CHECKOUT WAS PERFORMED AND IT WAS NOTED THAT THE SITE'S CAMERA WAS CONNECTED AND INITIALLY GREEN IN THE SOFTWARE. WHEN A DEMO CASE WAS DONE, IT SAID LOCALIZER NOT CONNECTED. BOTH LEDS (LIGHT-EMITTING DIODE) ON THE CAMERA WERE GREEN. THE CLINICAL CONSULTANT (CC) TROUBLESHOT BY RE-SEATING THE CAMERA CABLE FROM THE SENSOR CONTROL UNIT (SCU) AND ATTEMPTED BYPASSING THE INPUT / OUTPUT HUB CABLE FROM THE CENTRAL PROCESSING UNIT (CPU) DIRECTLY TO THE SCU BUT NO CHANGE IN SOFTWARE. AFTER CHECKING THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX UTILITY, THE CC FOUND NO FAULTS LISTED ON CAMERA OR SCU AND NO ERRORS IN THE POSITION SENSOR UNIT (PSU) LOGS. HOWEVER MULTIPLE INTERNAL STROBE ERRORS WERE NOTED IN THE SCU LOGS. THE PROBABLE CAUSE WAS LIKELY A SECONDARY ISSUE NOT RELATED TO THE INPUT/OUTPUT (I/O) PANEL EXCHANGE. THERE WAS NO PATIENT PRESENT WHEN THE EVENT OCCURRED.

  MAUDE report 13764748 ↗
• MalfunctionFeb 10, 2022Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE'S SYSTEM UNEXPECTEDLY POWERED DOWN DURING A CASE. THE SITE POWERED ON THE SYSTEM, BUT STATES THEIR PATIENT REGISTRATION WAS LOST. THE SYSTEM WAS NOT UNDER AN ACTIVE SSA. THERE WAS NO IMPACT TO THE PATIENT OUTCOME AND DELAY WAS 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507306 ↗
• MalfunctionNov 15, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE BEING PERFORMED WAS A CRANIOTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808793 ↗
• InjuryApr 14, 2021Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY. IT WAS REPORTED THAT DURING A POSTERIOR FUSION OF T7 TO THE PELVIS, WHILE PLACING THE LEFT ILIAC SCREW, THE SCREW BROKE OUT AND WENT MEDIAL. IT WAS NOTED THAT THE SCREW SIZE WAS A 9.5 X 100. THE PATIENT WAS RE-SPUN AND THE SCREW WAS REPOSITIONED SUCCESSFULLY, AND THE PROCEDURE WENT ON AS PLANNED. THERE WAS LESS THAN AN HOUR DELAY TO THE PROCEDURE AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11667982 ↗
• MalfunctionOct 20, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT AN RESPONSIVE NEUROSTIMULATION (RNS) LEAD WAS PLACED INACCURATELY. IT WAS REPORTED THAT THEY WERE USING A STEREOTACTIC FRAME BIOPSY PROCEDURE. THEY WERE PLACING THE RNS LEADS ON THE LEFT AND RIGHT SIDE OF THE PATIENT. THEY FOUND THAT THE LEAD WAS PLACED INACCURATELY BY LOOKING AT THE POST OP SCAN AND SAW THAT THE RNS LEAD WAS IN THE INCORRECT PLACE ON THE LEFT SIDE OF THE PATIENT. IT WAS SUPERIOR ABOUT 2.5 INCHES. THEY CHECKED THE COORDINATES ON THE SYSTEM AND SAY THAT THE VERTICAL COORDINATE WAS DISPLAYED AS NEGATIVE 11, BUT THE SURGEON DID POSITIVE 11 ON THE FRAME, WHICH WOULD CAUSE THE INACCURACY. THEY LEFT THE RNS LEAD IN. NO SURGERY WAS SCHEDULED TO REMOVE THE LEAD AT THE TIME. THERE WAS NO DELAY TO THE PROCEDURE. IT WAS NOTED THAT THE PATIENT WAS IMPACTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THERE WAS NO AFFECT TO THE PATIENT, JUST THAT THE LEADS WERE PLACED INACCURATELY. THE LEADS BEING PLACED INACCURATELY DID NOT HAVE ANY ADVERSE CONSEQUENCES. IT WAS UNKNOWN IF A SECOND PROCEDURE WOULD BE SCHEDULED, BUT IF ONE IS, T

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10706339 ↗
• MalfunctionMay 14, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE STAFF MONITOR IS FLICKERING AND HAS BLUE LINES RUNNING DOWN THE SCREEN. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 10057208 ↗
• MalfunctionMar 18, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE HEALTH CARE PROFESSIONAL (HCP) TRIED TO LOAD A CT SCAN VIA CD, THE SOFTWARE DID NOT RECOGNIZE THE DISC. THE HCP WAS ABLE TO SUCCESSFULLY LOAD A MRI VIA CD. THE MRI DID NOT SEEM ADEQUATE FOR REGISTRATION BECAUSE IT WAS FAIRLY POOR QUALITY, THE SKIN WASN'T SMOOTH, AND THE TIP OF THE NOSE WAS MISSING. TECHNICAL SERVICE RECOMMENDED HAVING A NEW CD BURNT WITH ONLY THE RAW DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) FILES. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9848483 ↗
• MalfunctionNov 15, 2019Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CAUSE OR CONTRIBUTING FACTORS RELATED TO THE REPORTED ISSUE WERE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9328420 ↗
• MalfunctionJul 1, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM WAS SHOWING NO INPUT DETECTED ON BOOT UP. THEY ATTEMPTED TO REBOOT A FEW TIMES WITH THE SAME RESULT. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8748404 ↗
• MalfunctionJun 27, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING THE CASE THE MAIN CART MONITOR DISPLAYED NO INPUT AND THE SURGEON MONITOR WENT BLACK. THE COMPUTER FAN WAS NOT CYCLING. THE MEDTRONIC REPRESENTATIVE WHO WAS PRESENT BYPASSED THE VIDEO SPLITTER AND THE SOFTWARE APPEARED ON THE SURGEON MONITOR. THE SITE CONTINUED WITH ONE MONITOR. THERE WAS NO DELAY TO THE CASE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS LATER NOTED THAT THE VIDEO SPLITTER WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8742772 ↗
• MalfunctionJun 9, 2019Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT USER LOADED A DISC BUT THE IMAGES WERE INVERTED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8681440 ↗
• MalfunctionMay 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE VERTEK ARM WAS NOT TIGHTENING. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8619985 ↗
• MalfunctionMay 14, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SURGEON MONITOR WAS FLICKERING. IT WOULD INTERMITTENTLY FLICKER WHEN THE CABLE WAS MANIPULATED. SITE GOT IT IN A POSITION WHERE IT DISPLAYED VIDEO NORMALLY AND USED IT FOR THE UPCOMING CASE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8609539 ↗
• MalfunctionApr 15, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION. THE REP INDICATED THAT THEY WERE UNABLE TO SEE THE MICROSCOPE BRACKET IN THE TRACKING WINDOW. THERE WAS A GREEN LINE OF COMMUNICATION IN THE SOFTWARE. THE BRACKET WAS REMOVED AND RE-ADDED, BUT THE BRACKET STILL COULD NOT TRACK. THE MICROSCOPE WAS IN INSTRUMENT PORT B AND THE REP WAS UNSURE IF THIS MICROSCOPE HAD WORKED PREVIOUSLY, BUT THE BRACKET NUMBER DID MATCH TO THE SW. THE REP REBOOTED THE SYSTEM AND THE ISSUE RESOLVED. THERE WAS NO DELAY IN PROCEDURE AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8515500 ↗
• MalfunctionApr 11, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER REPLACING THE COMPUTER THE REP WAS ADDING TOOL CARDS AND THE CAMERA STATED LOCALIZER NOT CONNECTED. SHE STATED THAT THE LEFT LIGHT WAS FLASHING GREEN, THEN THE SECOND LIGHT WAS SOLID GREEN AND THERE WAS NO AMBER LIGHT. SHE STATED THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) ONLY HAD 2 GREEN LIGHTS NOT 3. AFTER REPLACING THE CSU THE CAMERA SHOWED GREEN LEDS, BUT THE NDI TOOLBOX WOULD NOT CONNECT. THE SCU WAS SHOWING A SOLID AMBER FAULT LIGHT AND THE POWER INDICATOR ON THE LEFT SIDE WAS FLASHING AMBER. TECHNICAL SERVICES (TS) HAD THE REP BYPASS THE USB CONNECTION ON THE I/O HUB DIRECTLY INTO THE SCU AND MOVE THE POWER CABLE PORT ON THE UPS WITH NO CHANGE. THE REP CHECKED ALL THE COMPUTER CONNECTIONS WITH A WITH ANOTHER WORKING NAVIGATION SYSTEM AND EVERYTHING WAS CORRECT. TS HAD THE REP CHECK FOR LIGHT ON THE INSIDE OF THE I/O CIRCUIT BOARD AND THE REP COULD NOT SEE ANY LIGHTS. THE SOFTWARE WAS DISPLAYING LOCALIZER DISCONNECTED AND WAS SHOWING THE SURGEON MONITOR AS DISCONNECTED.

  Patient problems: No Patient Involvement

  MAUDE report 8503676 ↗
• MalfunctionMar 18, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE SYSTEM BECAME UNRESPONSIVE. THE MANUFACTURE REPRESENTATIVE RESTARTED THE SYSTEM AND IT STATED NO VIDEO SIGNAL AND THE COMPUTER FAN STAYED ON FOR 15 SECONDS AND THEN TURN OFF. HE DID A HARD REBOOT OF THE SYSTEM AND THE ISSUE PERSISTED. HE DID ANOTHER HARD REBOOT AND SYSTEM BOOTED UP AS EXPECTED. TECHNICAL SERVICES (TS) REQUESTED HE DO A SHUTDOWN THROUGH THE SOFTWARE AND HE WAS UNABLE TO REPLICATE ISSUE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8429583 ↗
• MalfunctionDec 28, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION FROM A USER FACILITY REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION. THE CALLER REPORTED THAT THE OPERATING ROOM STAFF WERE OBSERVING THE MONITORS ON THE SYSTEM AND IN THE OPERATING ROOM FLICKERING. THE CALLER THEN REPORTED THAT "THEY HAD THE OPERATING ROOM MONITORS SLAVED OUT. IT DISPLAYED A LOGO AND THEN WENT BLACK AND THEN CAME BACK UP FUNCTIONING AS INTENDED." THERE WAS A PATIENT PRESENT AT THE TIME OF THIS ISSUE, BUT THERE WAS NO IMPACT TO PATIENT OUTCOME AND THE DELAY IN SURGERY WAS LESS THAN ONE HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8204337 ↗
• MalfunctionDec 28, 2018Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THE SYSTEM WAS MOVING VERY SLOW AND THEN BECAME UNRESPONSIVE ON THE BLUE SCREEN. A SOFT REBOOT WAS COMPLETED, BUT THE SYSTEM WAS STILL SLOW. IT WAS NOTED THE PATIENT SCREEN WAS SHOWING OVER 70% FULL. TECHNICAL SERVICES (TS) RECOMMENDED DELETING PATIENTS AND CHECKING/DELETING OLD VERSIONS OF SOFTWARE. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8202906 ↗
• MalfunctionDec 17, 2018Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM CANNOT LOAD INTO ADMINISTRATOR APPLIANCE. THE SYSTEM STOPPED RESPONDING WHEN ATTEMPTING TO LOAD INTO THE SCREEN AND A HARD RESTART WAS REQUIRED.

  Patient problems: No Patient Involvement

  MAUDE report 8170772 ↗
• MalfunctionNov 26, 2018Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE SURGEON MONITOR OF THE NAVIGATION SYSTEM WOULD BLINK WHEN A BOVIE ELECTRICAL CUTTER IS INTRODUCED INTO THE FIELD OF NAVIGATION. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8103077 ↗
• MalfunctionOct 10, 2018Human-Device Interface Problem; Material Integrity Problem; Human-Device Interface Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BULKHEAD ON THIS SYSTEM WAS DAMAGED AND THE NAVIGATION SYSTEM WAS UNABLE TO CONNECT TO THE IMAGING SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED.

  Patient problems: No Patient Involvement

  MAUDE report 7953363 ↗
• MalfunctionOct 8, 2018Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE DISC WAS LOADED AND THE SITE SAW THE STUDY WAS A NAME ON THE RIGHT-HAND SIDE OF THE IMPORT SCREEN. THE SITE SELECTED "DOWNLOAD ALL" AND THE SERIES DISPLAYED "GREEN CHECKS" ON THE RIGHT-HAND SIDE BUT THERE WAS NO NAME OF THE PATIENT. THE SITE WAS UNABLE TO SEE THE DOWNLOADED PATIENT ON THE PATIENT SCREEN. THE SITE ORGANIZED BY DATA AND ATTEMPTED TO RELOAD THE PATIENT AGAIN BUT NEVER SAW THE PATIENT. THE USE OF NAVIGATION WAS ABORTED. THERE WAS NO PATIENT IMPACT AND THE SURGERY WAS COMPLETED WITH AN HOUR DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7945075 ↗