NA 9734061Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00613994667458), received between Dec 2, 2016 and May 1, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (8 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A POSITION SENSOR UNIT (PSU) FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942502 ↗
• MalfunctionAug 28, 2023Display 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 BOOM MONITORS WERE NOT WORKING. THE NEXT STEP WAS TO CHECK THE MONITORS OR THE CABLING TO THE MONITORS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632932 ↗
• MalfunctionMar 13, 2023Imprecision; Communication or Transmission Problem; Imprecision; Communication or Transmission Problem

  THE MANUFACTURER REPRESENTATIVE VISITED THE SITE, AND WHEN PLANNING, THEY COULD NOT SEE THE DISTANCE ERROR AND COULD NOT DUPLICATE THE PROBLEM EVEN AFTER THE SOFTWARE VERSION UPGRADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529602 ↗
• MalfunctionFeb 15, 2023Connection Problem; Environmental Compatibility Problem; Material Integrity Problem; Connection Problem; Environmental Compatibility Problem; Material Integrity Problem

  THE REPORTED ISSUE WAS THOUGHT TO BE RELATED TO THE ELECTRICAL GRID IN THE OPERATING ROOM SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378381 ↗
• MalfunctionAug 26, 2022Display or Visual Feedback Problem; Connection Problem; Display or Visual Feedback Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISMANTLED BY A THIRD PARTY COMPANY AND SOME COMMUNICATION CABLES WERE REMOVED. THE SYSTEM COMPUTER WAS NOT ABLE TO COMMUNICATE WITH THE CAMERA AND MONITOR/ TOOL INTERFACE UNIT (TIU.) THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300440 ↗
• MalfunctionJun 27, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT  THE CAMERA DOES NOT WORK. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAMERA WAS NOT DAMAGED. THE CAMERA WAS CONNECT BUT MAYBE THE POWER SUPPLY WAS DAMAGED. IT WAS NOTED THE CEILING NEEDED TO BE DISMANTLED IN ORDER TO CHECK IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14834122 ↗
• MalfunctionMay 31, 2022Connection Problem; Device Sensing Problem; Connection Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING A PLANNED MAINTENANCE (PM) THAT THE CAMERA WAS NOT COMMUNICATED WITH THE NAVIGATION SYSTEM. THE TOOLS WERE NOT VISIBLE TO THE CAMERA AND THE SYSTEM WAS THERE FOR UNABLE TO NAVIGATE. THE NEXT STEP WAS TO CHECK THE CAMERA, POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU), AND CABLE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547807 ↗
• MalfunctionSep 27, 2021Device Sensing Problem; Application Program Freezes or Fails to Launch; Device Sensing Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE FACILITY REBOOTED THE SYSTEM WITHOUT RESOLUTION. IT WAS REPORTED THAT THE TIU WAS RECONNECTED TO POWER, WHICH RESTORED FUNCTIONALITY AS THE POWER CABLE HAD BEEN DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532484 ↗
• MalfunctionAug 9, 2021Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO COMMUNICATION WITH THE CAMERA. NO PATIENT WAS PRESENT. IT WAS NOTED THAT THE CABLE CONNECTION, TRANSCEIVER, INTERFACE PANEL AND SENSOR CONTROL UNIT SHOULD BE CHECKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294596 ↗
• MalfunctionJun 10, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE BLUE BOX DID NOT TURN ON. ALL WORKED FINE WHEN FIRST CONNECTED WITH THE NAVIGATION TOOLS VISIBLE AND REGISTRATION OK. THE COMMUNICATION CABLE INSULATION WAS FOUND TO BE WORN. WHILE CHECKING THE CABLE THE TOOLS DISAPPEARED AND THEN CAME BACK AGAIN SIMULTANEOUSLY INDICATING BROKEN WIRES INSIDE THE CABLE. IT WAS NOTED THAT COMMUNICATION WITH THE AXIEM WAS LOST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975745 ↗
• MalfunctionMay 21, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE COMPUTER REBOOTED BY ITSELF. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862967 ↗
• MalfunctionMay 19, 2021Material 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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS NOT TURNING ON. THE CAMERA WAS NOT WORKING WHEN THE SYSTEM WAS TURNED ON. NO LIGHTS WERE ON THE CAMERA, AND THE STATUS SAID, "LOCALIZER IS NOT CONNECTED". NO PATIENT WAS INVOLVED. THE NEXT ACTION WAS TO REPLACE THE LOCALIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848242 ↗
• MalfunctionApr 7, 2021Connection Problem; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAMERA'S INDICATION LIGHTS WERE OKAY. AFTER THE SYSTEM WAS REBOOT, ALL WAS FINE, REGISTRATION WAS KEPT, AND NAVIGATION STEP WAS AVAILABLE. BUT THE SYSTEM WORKS SLOWLY EVEN IF ALL STORED PATIENTS WERE REMOVED. THE COMPUTER BEHAVIOR MIGHT INFLUENCE THE CAMERA COMMUNICATION. IN ADDITION THE MANUFACTURER REPRESENTATIVE NOTICED THAT THE TEMPERATURE IN THE SERVICE ROOM WAS HIGH (THIS ROOM CONTAINS THE POLESTAR RACK AND THE I7 SYSTEM COMPUTER), THIS WAS REPORTED TO THE HOSPITAL AND THE MANUFACTURER REPRESENTATIVE ASKED THEM TO LEAVE DOOR OPEN WHILE USING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627259 ↗
• MalfunctionMar 8, 2021Display 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 OF THE NAVIGATION SYSTEM WAS FLICKERING. IT WAS NOTED THAT THE REPORTED ISSUE PREVENTED USE OF THE SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440383 ↗
• MalfunctionMar 1, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE EMITTER WOULD NOT TRACK. IT WAS REPORTED THAT THE INSTRUMENT WINDOW DISPLAYED AN ORANGE DOTTED LINE FOR THE EMITTER. IT WAS NOTED THAT THE ISSUE OCCURRED PRE-OPERATIVE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392492 ↗
• MalfunctionFeb 2, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) CHECKOUT. IT WAS REPORTED THAT THE CRANIAL APPLICATION SOFTWARE WAS NOT WORKING AS DESIGNED. IT WAS REPORTED THAT THE APPLICATION SOFTWARE WAS REBOOTING CONTINUOUSLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. THE NEXT STEP WAS TO REPLACE THE CENTRAL PROCESSING UNIT (CPU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11266425 ↗
• MalfunctionOct 20, 2020Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EMITTER COMM/POWER CABLE WAS BROKEN, AND THE SYSTEM COULD NOT CONNECT TO THE EMITTER.

  Patient problems: No Patient Involvement

  MAUDE report 10706151 ↗
• MalfunctionSep 29, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SITE REPORTED ISSUES WITH THE NAVIGATION. THE COMPUTER STOPPED WORKING. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE NAVIGATION SYSTEM RESTARTED WHILE IN USE.

  Patient problems: No Patient Involvement

  MAUDE report 10599854 ↗
• MalfunctionMay 28, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE FACILITY WAS UNABLE TO TRANSFER PATIENT DATA THROUGH THE NETWORK. THE SITE REPORTED THAT THEY LOST SOME PATIENT DATA.

  Patient problems: No Patient Involvement

  MAUDE report 10097094 ↗
• MalfunctionFeb 21, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE MANUFACTURER REPRESENTATIVE HAS DONE SOME TESTS ON SITE AND THE POSITIONING SENSOR UNIT (PSU) COMPLETELY STOPPED WORKING. IT WAS BLACKED OUT AND NO LEDS WERE VISIBLE WHILE THE SYSTEM WAS TURNED ON. THE NAVIGATION INTERFACE UNIT (NIU) WAS WORKING HOWEVER AND THE MONITORS WERE ALSO FUNCTIONAL. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ROOT CAUSE OF THIS ERROR WAS A BROKEN MICROFUSE OF THE REMOTE CONTROL UNIT (RCU) SPECTRA UNIT.

  Patient problems: No Patient Involvement

  MAUDE report 9740919 ↗
• MalfunctionFeb 13, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE SITE INDICATED THE POSITION SENSOR UNIT (PSU) WAS NOT WORKING; NO LEDS WERE VISIBLE UPON SYSTEM STARTUP. A SITE VISIT WAS PLANNED.

  Patient problems: No Patient Involvement

  MAUDE report 9708571 ↗
• MalfunctionFeb 3, 2020Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM CANNOT BOOT UP AFTER POWERED ON. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 9658816 ↗
• MalfunctionDec 17, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WOULD NOT POWER UP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9481896 ↗
• MalfunctionDec 5, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE CUSTOMER IS COMPLAINING ABOUT THE FACT THAT AFTER EACH IMAGING SCAN, WHEN EVERYTHING IS SWITCH ON AGAIN, THE MICROSCOPE (DOES NOT MATTER WHAT SCOPE IT IS - LEICA OR PENTERO) AND THE NAVIGATION SYSTEM DO NOT COMMUNICATE ANYMORE. THIS RESULTS IN SCOPE-NAVIGATION IS NOT AVAILABLE IMMEDIATELY AFTER THE IMAGING SCAN. A RESTART OF THE NAVIGATION COMPUTER SOLVES THE SITUATION. BUT THIS COULD NOT BE THE SOLUTION THE EQUIPMENT WAS DESIGNED FOR. THE ISSUE WAS IDENTIFIED DURING A CRANIAL RESECTION PROCEDURE. THERE WAS NO DELAY TO THE PROCEDURE, AND NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415277 ↗
• MalfunctionNov 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, SOME DATA SERIES COULD NOT BE DOWNLOADED ONTO THE NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9317858 ↗