Stealthstation® S7™ 9733858 (UDI 00643169505742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 695 adverse event reports that list this exact device (DI 00643169505742), received between Oct 12, 2016 and Jun 4, 2026 — classified as 1 death, 15 injuries, 679 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (113 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 695 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Delayed Program or Algorithm Execution

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED. IT WAS REPORTED THAT THERE WAS SLOWED PROCESSING. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE REGISTRATION HAS BEEN HARD TO BE ACCURATE, AND THE REGISTRATION POINTS FOR ANATOMICAL REFERENCES CHANGE. IT WAS NOTED THAT THE ISSUE WAS STILL TO BE RESOLVED. PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE NAVIGATOR PUT THE INITIAL THREE ANATOMICAL POINTS AT RANDOM PLACES WHICH MAKES VERY HARD TO HAVE A GOOD REGISTRATION AND SOMETIMES THE SITE HAS FOUND DISCREPANCIES OF UP TO 2 CM IN THE NAVIGATION AND HAS COMPLAINED ABOUT THE PRECISION OF THE NAVIGATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WERE NO PATIENT HARMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398706 ↗
• MalfunctionMar 25, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S SCREEN SHOWED NOTHING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688025 ↗
• MalfunctionMar 19, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BIG TOUCH MONITOR WAS DEFECTIVE; THERE WAS A BLACK SCREEN AND NO POWER. THE SMALL MONITOR WORKED PERFECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640850 ↗
• MalfunctionMar 10, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED PRE-OPERATIVELY. IT WAS REPORTED THAT THE CAMERA EYES LOWERED BY THEMSELVES. PATIENT PRESENCE NOT PROVIDED. THE CAMERA ARM WAS LOOSE. THE ISSUE OCCURRED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558085 ↗
• MalfunctionFeb 13, 2026Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ARTICULATING ARM DID NOT WORK PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE VERTEK ARM DID NOT MAINTAIN ITS POSITION DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333318 ↗
• MalfunctionDec 22, 2025Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CABLE WAS PHYSICALLY DAMAGED BY CUSTOMER, SO EM FUNCTION WAS NOT WORKING. THERE WAS NO ISSUE WITH ALL THE OTHER FUNCTIONS OF THE DEVICE. THE ISSUE OCCURRED PRE-OPERATIVELY WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864394 ↗
• MalfunctionDec 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THIS EVENT WAS INCORRECTLY REPORTED BY THE CUSTOMER ON A NAVIGATION SYSTEM. THE SYSTEM INVOLVED WITH THIS EVENT WAS AN IMAGING SYSTEM. THERE WAS NO ISSUE WITH THE NAVIGATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696596 ↗
• MalfunctionDec 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ON 2025-NOV-18, (B)(4), (REP, HCP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE STAFF CART MONITOR WAS NOT WORKING AND WAS HAVING ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681875 ↗
• MalfunctionSep 12, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS NOT ABLE TO DETECT INSTRUMENTS FROM A DISTANCE. WHEN THE DISTANCE WAS DECREASED, IT DETECTED INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039090 ↗
• MalfunctionJul 31, 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 SCREEN SUDDENLY WENT BLACK WHEN THEY WERE HALFWAY THROUGH USING IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676466 ↗
• MalfunctionJul 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. THE EVENT OCCURRED DURING A BRAIN TUMOR RESECTION PROCEDURE. THE PATIENT HAD TO UNDERGO REINTERVENTION BECAUSE PART OF THE TUMOR WAS LEFT UNREMOVED ONE WEEK AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459369 ↗
• InjuryJun 30, 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 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INACCURACY. AFTER SCREW IMPLANTATION, THE PATIENT LOST CRANIAL NERVE FUNCTION (CNF) RESPONSE ON THE LEFT SIDE AND THEY USED AN IMAGING SYSTEM TO CHECK THE PLACEMENT. THE SPIN SHOWED THAT THE SCREWS WERE 2-3MM TOO MEDIAL AND WERE LEANING AGAINST THE ALREADY STRETCHED SPINAL CORD. THE SCREWS WERE THEN EXPLANTED AND NEW CANALS WERE MADE FREE HANDEDLY AND SCREWS WERE IMPLANTED WITHOUT ISSUE. SOME CNF RESPONSE WAS RECOVERED AND THE PATIENT WAS MOVED TO THE CRITICAL CARE UNIT. THE PATIENT WAS MONITORED AND THE LOSS OF RESPONSE HAD AN UNSPECIFIED EXTENT. THE ANTERIOR TIBIAL NERVE RESPONSE WAS LOST AND CAME BACK 24 HOURS AFTER SURGERY. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: Nerve Damage; Nervous System Injury; Unspecified Nervous System Problem

  MAUDE report 22362048 ↗
• MalfunctionJun 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A FACING ISSUE IN THE NAVIGATION SYSTEM TO DOWNLOAD PATIENT DATA THROUGH PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS). THE MANUFACTURER REPRESENTATIVE (REP) RE-INTEGRATED THE PACS SETTING IN THE NAVIGATION SYSTEM. AFTER RE-CONFIGURATION OF THE PACS SETTING, THE PATIENT DATA WAS DOWNLOADING AGAIN THROUGH THE PACS IN NAVIGATION SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327679 ↗
• MalfunctionJun 20, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THERE WAS A LOCALIZER FAULTED ERROR. IT WAS UNKNOWN IF THERE WAS A PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298412 ↗
• MalfunctionJun 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296907 ↗
• 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 22197226 ↗
• MalfunctionMay 27, 2025Communication 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 C-ARM INTEGRATION WAS NOT WORKING WITH THE NAVIGATION SYSTEM AND THEY WERE UNABLE TO TRANSFER IMAGES TO THE NAVIGATION SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091770 ↗
• MalfunctionMay 20, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DATA IMPORT FAILURE FROM THE IMAGING SYSTEM TO THE NAVIGATION SYSTEM. HOWEVER, IT WORKED AS INTENDED AFTER THE NETWORK CABLE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053226 ↗
• MalfunctionMay 8, 2025Communication 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 DATA IMPORTED FROM THE IMAGING SYSTEM TO THE NAVIGATION SYSTEM WAS INCOMPLETE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984325 ↗
• MalfunctionApr 28, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT ABLE TO ADD RESULTS TO THE CRANIAL APPLICATION. IT WAS NOT POSSIBLE TO UPLOAD THE STUDY CD TO THE CRANIAL SOFTWARE IN THE NAVIGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918453 ↗
• MalfunctionApr 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN ORTHO (THA AND TKA) PROCEDURE. IT WAS REPORTED THAT THE IMAGE ON TRAJECTORY 1 ROTATED AT A CERTAIN ANGLE. DURING TROUBLESHOOTING, THERE WAS NO PROBLEM WITH THE MACHINE OR INSTRUMENT FOUND. WHEN PUTTING THE INSTRUMENT AT THAT ANGLE, THE MACHINE ROTATED THE IMAGE. IT WAS SUGGESTED TO TILT THE IMAGING SYSTEM TO MEET THE ANGULATION OF THE ANATOMY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902652 ↗
• MalfunctionApr 18, 2025Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE COMPUTER NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE COMPUTER WAS FAULTY, AFTER A COUPLE OF MINUTES, "THE COMPUTER COMPONENT HIT UP" AND THE SCREEN STOPPED SHOWING THE COMPUTER CLEAR. "THE COMPUTER COMPONENT HIT UP" MEANT THAT THE MONITOR SCREEN WAS FLICKERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865555 ↗
• MalfunctionApr 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE TOUCH MONITOR WAS NOT WORKING AND OPTICAL TRACKING MODE WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774605 ↗
• MalfunctionApr 3, 2025Communication or Transmission Problem; Power Problem; Communication or Transmission Problem; Power Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767277 ↗
• MalfunctionMar 31, 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 COULD NOT DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730224 ↗