Stealthstation® S7™ 9733858 (UDI 00613994450968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 984 adverse event reports that list this exact device (DI 00613994450968), received between Sep 21, 2016 and Apr 9, 2026 — classified as 8 deaths, 52 injuries, 924 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (123 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 984 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A SCREEN PROBLEM. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE SCREEN DISPLAY WAS INCOMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832787 ↗
• MalfunctionAug 27, 2025Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program 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 THE SYSTEM SCREEN WAS BLANK, AND A "NO SIGNAL" MESSAGE SHOWED ON MONITOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902521 ↗
• MalfunctionJun 12, 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 THE MONITOR HAD NO SIGNAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197404 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT OPTICAL MODE WAS NOT WORKING. THE OPTICAL INSTRUMENT WAS NOT DETECTED BY THE CAMERA. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS RELATED TO THE CAMERA, NOT THE INSTRUMENT. IT WAS OBSERVED DURING PREVENTATIVE MAINTENANCE (PM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125220 ↗
• MalfunctionMar 14, 2025Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM SHUT DOWN DURING USE. THERE WAS A DELAY OF LESS THAN ONE HOUR, AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607469 ↗
• MalfunctionFeb 21, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS REMOVED FROM THE PROCEDURE. IT WAS SUSPECTED THAT THIS OCCURRED AFTER THE UPGRADE TO CRANIAL 3.1.4 RELATED TO A FIELD ACTION SOFTWARE INSTALLATION. THE MANUFACTURER REPRESENTATIVE (REP) ASSISTED THE SITE ON ADDING THE INSTRUMENT AGAIN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INSTRUMENT HAD TO BE ADDED FROM THE "ADMIN TAB."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437211 ↗
• MalfunctionJan 29, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THE OPTICAL SYSTEM DID NOT WORK. PATIENT PRESENCE UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264299 ↗
• MalfunctionJan 23, 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 THE HOME SCREEN WAS NOT SHOWING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218810 ↗
• MalfunctionDec 9, 2024Display 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 THERE WAS NO VIDEO SIGNAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878127 ↗
• MalfunctionDec 4, 2024Display 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 THERE WAS A BLANK DISPLAY ON THE LIQUID-CRYSTAL DISPLAY (LCD) SURGEON SCREEN. THERE WAS TROUBLESHOOTING PRESENT. IT WAS REPORTED THAT ALL CONNECTIONS WERE RE-CONNECTED BUT THE DISPLAY WAS STILL BLANK. THE PROBABLE CAUSE NOTED WITH AN ISSUE WITH THE LCD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845998 ↗
• MalfunctionNov 27, 2024Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM COULD NOT IMPORT PATIENT DATA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795520 ↗
• MalfunctionNov 26, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC BOX WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785672 ↗
• MalfunctionNov 26, 2024Mechanical Problem; Connection Problem; Mechanical Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED. IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE CAMERA. PATIENT PRESENCE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777558 ↗
• MalfunctionOct 29, 2024Display 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 THE SURGEON MONITOR COULD NOT DISPLAY ANYTHING INTERMITTENTLY. TESTED WITH ANOTHER CABLE, AND THE ISSUE WAS NOT SOLVED. IT WAS THEN TESTED WITH ANOTHER MONITOR, WHICH SOLVED THE ISSUE. SOFTWARE WAS ALSO UPGRADED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556891 ↗
• MalfunctionOct 17, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 THE SYSTEM DISPLAYED 'NO SIGNAL' UPON BOOT-UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469842 ↗
• MalfunctionOct 14, 2024Display 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 THE SURGEON MONITOR HAD A BLACK SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439993 ↗
• MalfunctionOct 7, 2024Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE TRIED TO LOAD THE PATIENT DIGITAL VIDEO DISC (DVD) WRITTEN FROM NAVIGATION SYSTEM PLANNING STATION THE DVD WAS NOT GETTING DETECTED IN THE IMPORT WINDOW. BUT THE SAME DVD WAS DETECTED AGAIN IN THE NAVIGATION SYSTEM PLANNING STATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383352 ↗
• MalfunctionOct 4, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT 'NO SIGNAL' WAS DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20377367 ↗
• MalfunctionSep 17, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DID NOT BOOT UP. TROUBLESHOOTING CONFIRMED THAT THE POWER CABLE WAS PROPERLY CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239928 ↗
• MalfunctionSep 17, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 THE COMPUTER FAILED TO BOOT UP. IT WAS FOUND THE COMPUTER WAS REPORTING HARDWARE ERRORS DURING START UP. ONCE IT DID START, THE COMPUTER WOULD DROP WHILE SITTING IDLE. THE PROBABLE CAUSE WAS THAT THE MOTHERBOARD AND/OR POWER SUPPLY IN COMPUTER WERE FAULTY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238806 ↗
• MalfunctionSep 17, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO SIGNAL DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238733 ↗
• MalfunctionSep 16, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING A TRAINING SESSION, THE COMPUTER SHOWED LOW PERFORMANCE WHILE THE STAFF WAS PERFORMING SOME TESTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230252 ↗
• MalfunctionSep 10, 2024Use of Device Problem; Application Program Freezes or Fails to Launch; Use of Device 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 THE MACHINE COULD NOT BOOT UP. THE MONITOR SHOWED NO SIGNAL, AND THE COMPUTER FAN DID NOT MAKE A SOUND. THERE WAS NO PATIENT INVOLVEMENT. THE PROBABLE CAUSE WAS NOTED TO THE COMPUTER MALFUNCTIONING,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179876 ↗
• MalfunctionSep 6, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT BOOTING COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164660 ↗
• MalfunctionAug 22, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program 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 THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT AND THERE WAS A MESSAGE IN THE SCREEN INDICATING THAT IT DOES NOT HAVE VIDEO SIGNAL. THE PROBABLE CAUSE WAS A CPU FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031244 ↗