Stealthstation® S7™ 9734894Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169105232), received between Apr 20, 2017 and Mar 22, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHEN THE SYSTEM IS POWERED ON, THE MONITOR SHOWS "NO SIGNAL" AND THE CAMERA DOES NOT BEEP. THE FAN CAN BE HEARD CYCLING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543931 ↗
• MalfunctionAug 22, 2019Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE IMAGES ON THE SYSTEM WERE INVERTED. IT WAS NOTED THAT THE PIXEL OFFSET SETTINGS HAD ALREADY BEEN ADDED TO THE OVERRIDES FILE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8921136 ↗
• MalfunctionJun 18, 2019Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED INTRA-OPERATIVELY OF AN ELECTRODE AND PROBE PLACEMENT. IT WAS REPORTED THAT THE SITE REPORTED THAT THE LASER FIBER WAS PLACED 2MM LEFT INACCURATE USING THE LESKELL FRAME. THEY REPOSITIONED AND IT WAS STILL OFF PLAN. SURGEON CONTINUED WITH CASE WITH LASER FIBER PLACEMENT BEING ADEQUATE FOR HIS PURPOSE. NO IMPACT TO PATIENT AND LESS THAN AN HOUR OF DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8710185 ↗
• MalfunctionMay 29, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED " NO SIGNAL" ON A CONSISTENT BASIS AFTER THE SITE DELETED PATIENTS FROM THE SYSTEM. WILSON DISCONNECTED THE AXIEM BOX THEN RESTARTED BUT IT STILL DISPLAYED NO SIGNAL. THE WAS NO PATIENT PRESENT. THE REPRESENTATIVE BYPASSED THE VIDEO SPLITTER AND WAS UNABLE TO REPLICATE BEHAVIOR OF MONITORS GOING IN AND OUT, WAS ABLE TO OCCASIONALLY REPLICATE WITH THE VIDEO SPLITTER CONNECTED. WHEN THE SCREENS CAME BACK, THEY WERE AT THE SPLASH SCREEN INDICATING THE COMPUTER IS BOOTING UP AND FUNCTIONING. THE STAFF CART HAD NO SIGNAL WHILE THE SURGEON CART HAD NO DISPLAY AT ALL. THE REPRESENTATIVE RE PLUGGED THE INTERCONNECT CABLE BETWEEN THE TWO, AND BOTH SCREENS NOW WORK AS INTENDED.

  Patient problems: No Patient Involvement

  MAUDE report 8651225 ↗
• MalfunctionMay 6, 2019Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE SITE WAS CONTACTED FOR PATIENT INFORMATION AND IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8584492 ↗
• MalfunctionAug 1, 2017Computer Software Problem; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected; Computer Software Problem; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected

  A SITE NEURO COORDINATOR REPORTED THAT, WHILE IN A CATHETER BASED PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE WHEN LOADING A PATIENT EXAM. THE SYSTEM DISPLAYED THAT THE EXAM WAS RECEIVED BUT THE PROMPT WOULD STAY FOR TEN MINUTES. THE CD DRIVE WAS REPORTED TO HAVE TURNED OFF AND NOT SPINNING THOUGH THE UNIT WAS INITIALLY WORKING. THE UNSTRUCTURED DVR WAS SELECTED AND THE NAVIGATION SYSTEM WAS RESTARTED TWICE. THE REPRESENTATIVE REPORTED THAT THE DISC MAY HAVE CONTINUED A LOT OF DATA. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6758086 ↗
• MalfunctionMay 4, 2017Display or Visual Feedback Problem; Device Stops Intermittently; Device Operates Differently Than Expected; Display or Visual Feedback Problem; Device Stops Intermittently; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE MONITOR ON THE NAVIGATION SYSTEM FLICKERED DURING NAVIGATION. RESTARTING THE NAVIGATION SYSTEM RESOLVED THE REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6545517 ↗
• MalfunctionMay 4, 2017Display or Visual Feedback Problem; Device Stops Intermittently; Device Operates Differently Than Expected; Display or Visual Feedback Problem; Device Stops Intermittently; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE MONITOR ON THE NAVIGATION SYSTEM FLICKERED DURING NAVIGATION. RESTARTING THE NAVIGATION SYSTEM RESOLVED THE REPORTED ISSUE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6545469 ↗
• MalfunctionMay 4, 2017Display or Visual Feedback Problem; Device Stops Intermittently; Display or Visual Feedback Problem; Device Stops Intermittently

  A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE MONITOR WAS INTERMITTENTLY LOSING DISPLAY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6544470 ↗
• MalfunctionMay 2, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally; Display or Visual Feedback Problem; Device Operates Differently Than Expected; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Display or Visual Feedback Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, A BLACK STRIP DISPLAY APPEARED AND THE MONITOR FLICKERED WHILE LOADING EXAMS. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6536867 ↗
• MalfunctionApr 20, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT, WHILE MANIPULATING EXAMS IN THE CRANIAL APPLICATION SOFTWARE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE. A HARD RESTART OF THE NAVIGATION SYSTEM RESOLVED THE REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6508370 ↗