N/A 9733449 (UDI 00613994378422)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00613994378422), received between Oct 7, 2016 and Jan 31, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (22 reports).

28 other recalls cover devices cleared under the same FDA submission (K001284); they may or may not involve this specific model.

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.

• MalfunctionJan 31, 2025Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE OUTSIDE OF PROCEDURE. IT WAS REPORTED IT WAS UNCLEAR WHETHER THERE WAS A STRAIGHT SUCTION DEFORMATION, OR WHETHER VERIFICATION COULD BE DONE OR NOT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283026 ↗
• MalfunctionJan 30, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT IT WAS DIFFICULT TO REGISTER THE PROBE INSTRUMENT. THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS NOTED THAT AN INCISION WAS MADE WHEN THE ISSUE OCCURRED. IT WAS REPORTED THAT THE SITE WAS ABLE TO REGISTER THOUGH IT WAS HARD. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PROBE AND OTHER INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277662 ↗
• MalfunctionDec 27, 2024Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE STRAIGHT SUCTION BROKE FROM THE ROOT REGION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026369 ↗
• MalfunctionNov 12, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD TWO STRAIGHT SUCTION PROBES THAT HAD BEEN BENT AND WERE NOT NAVIGABLE. NO PATIENT WAS PRESENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663632 ↗
• MalfunctionSep 9, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO VERIFY THE STRAIGHT SUCTION FOR APPROXIMATELY 5-10 MINUTES. AFTER INITIAL TROUBLESHOOTING ATTEMPTS WERE MADE, THE SURGEON MANUALLY MANIPULATED THE TIP OF THE SUCTION IN THE DIVOT UNTIL VERIFICATION WAS ACHIEVED. THE CASE PROCEEDED NORMALLY AFTER THIS POINT WITH THE SURGEON CONFIRMING ACCURACY OF THE SUCTION. THERE WAS A SURGICAL DELAY OF ABOUT 10 MINUTE DELAY. THERE WAS NO IMPACT ON THE PATIENT. THE BELOW STEPS WERE PERFORMED FOR TROUBLESHOOTING: (1) SWITCHED FROM FLAT EMITTER TO SIDE EMITTER. THERE WAS NO CHANGE. (2) THE SITE TRIED OTHER EM INSTRUMENTS. ALL OTHER EM INSTRUMENTS VERIFIED WITHOUT PROBLEMS. (3) INSPECTED GEOMETRY ERROR DURING FAILED VERIFICATION ATTEMPTS. STRAIGHT SUCTION GEOMETRY ERROR WAS PERSISTENTLY BELOW 2.0 MM. (4) INSPECTED DISTANCE-TO-DIVOT VALUE DURING FAILED VERIFICATION. DISTANCE-TO-DIVOT VALUE WAS CONSTANTLY ABOVE 2.5 MM DURING VERIFICATION ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390954 ↗
• MalfunctionMar 26, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS POSSIBLY DUE TO THE EMITTER AND NOT THE SUCTIONS.

  Patient problems: No Patient Involvement

  MAUDE report 9883605 ↗
• MalfunctionMar 26, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS POSSIBLY DUE TO THE EMITTER AND NOT THE SUCTIONS.

  Patient problems: No Patient Involvement

  MAUDE report 9883547 ↗
• MalfunctionJan 2, 2020Material Integrity Problem; Material Integrity Problem

  ON 2019-DEC-12 INFORMATION WAS RECEIVED STATING THAT PATIENT INFORMATION WAS DENIED BY SITE. 2020-JAN-13 SURGEON NAME PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9537984 ↗
• MalfunctionDec 23, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THE STRAIGHT SUCTION WAS 3-5 MILLIMETERS INACCURATE. IT WAS NOTED ALL OTHER INSTRUMENTS WERE ACCURATE. THIS ISSUE OCCURRED INTRAOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513398 ↗
• MalfunctionDec 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THERE WAS AN ISSUE WITH THE STRAIGHT SUCTION INSTRUMENT. THE SUCTION WAS BAD AND HAD BEEN PULLED FROM ONE OF THE SETS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9426907 ↗
• MalfunctionNov 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, A STRAIGHT SUCTION WAS REPORTED TO BE BENT IN THE SITE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9340778 ↗
• MalfunctionSep 6, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION HAD DIFFICULTY VERIFYING. THE SURGEON ENDED UP HAVING TO ROTATE THE SUCTION TO THE LEFT BEFORE IT WOULD VERIFY. THE ISSUE WAS ABLE TO BE REPLICATED BY A MANUFACTURING REPRESENTATIVE. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8970781 ↗
• MalfunctionJul 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE SUCTION WAS NOT OPERATING AS DESIGNED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8782348 ↗
• MalfunctionJun 21, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION NEEDED REPAIR.. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8722433 ↗
• MalfunctionJun 19, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION HAD DIFFICULTY VERIFYING. REPRESENTATIVE STATED THAT THE GEOMETRY ERROR WAS HIGH, AND SITE WAS HAVING TROUBLE VERIFYING IT CONSISTENTLY. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF 10 MINUTE. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713609 ↗
• MalfunctionJun 13, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE HAD THREE STRAIGHT SUCTIONS THAT WERE DAMAGED. THERE WAS LESS THEN AN HOUR DELAY TO THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT¿S OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8698250 ↗
• MalfunctionJun 11, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHEN TESTING WITH A DEMO HEAD, THE CURVED SUCTION TRACKING WAS OFF SUPERIOR ON SCREEN THAN ACTUAL POSITION ON THE DEMO HEAD. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8685668 ↗
• MalfunctionMay 28, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT STRAIGHT SUCTION WAS BENT. THERE WAS NO PATIENT PRESENT AT WHEN THE ISSUE OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8646001 ↗
• MalfunctionApr 12, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT PICKING UP ANY OF THE PATIENT OR INSTRUMENT TRACKERS. THE SITE WAS ABLE TO RESOLVE THE ISSUE BY RESTARTING THE SYSTEM. IT WAS CONFIRMED BY THE REPRESENTATIVE THAT THE SYSTEM WAS FUNCTIONING CORRECTLY, HOWEVER, THERE WERE INSTRUMENTS THAT WOULD NOT VERIFY. THE TOTAL DELAY OF PROCEDURE IS UNKNOWN, BUT THERE WERE NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8510029 ↗
• MalfunctionApr 12, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT PICKING UP ANY OF THE PATIENT OR INSTRUMENT TRACKERS. THE SITE WAS ABLE TO RESOLVE THE ISSUE BY RESTARTING THE SYSTEM. IT WAS CONFIRMED BY THE REPRESENTATIVE THAT THE SYSTEM WAS FUNCTIONING CORRECTLY, HOWEVER, THERE WERE INSTRUMENTS THAT WOULD NOT VERIFY. THE TOTAL DELAY OF PROCEDURE IS UNKNOWN, BUT THERE WERE NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8509961 ↗
• MalfunctionMar 28, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT WHILE NAVIGATING, THE SURGEON FELT 3 MM INACCURATE WITH THE STRAIGHT SUCTION. THE SITE OPENED A NEW SET, VERIFIED THE NEW STRAIGHT SUCTION, AND WERE ACCURATE. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461596 ↗
• MalfunctionMar 8, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE REP INDICATED THAT THE EXACT CAUSE OF THE DAMAGE WAS UNKNOWN, BUT NOTED IT WAS LIKELY DUE TO PREVIOUS CASES OR DAMAGED DURING STERILE PROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404639 ↗
• MalfunctionFeb 14, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY DURING THE NAVIGATE TASK AND DELAYED THE SURGERY BY LESS THAN ONE HOUR. IT WAS REPORTED THAT THE SITE HAD DIFFICULTY VERIFYING THEIR STRAIGHT SUCTION IN SURGERY. AFTER MANIPULATING THE POSITION OF THE INSTRUMENT, THE SURGEON WAS ABLE TO VERIFY THE SUCTION. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340231 ↗
• MalfunctionFeb 11, 2019Imprecision; Imprecision

  (B)(6) 2019, (B)(4) - (HCP, REP) MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY DURING THE NAVIGATE TASK AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THE SURGEON FELT INACCURATE WITH THE STRAIGHT SUCTION (3 MM) BUT NO OTHER INSTRUMENT. THE SURGEON ABORTED THE USE OF THE NAVIGATED SUCTION AND USED A PROBE TO CONFIRM POSITION. THE MEDTRONIC REPRESENTATIVE NOTED THAT THE SUCTION DID NEED SLIGHT MANIPULATION TO VERIFY BUT ONLY DISPLAYED A DISTANCE TO DIVOT AROUND 2.1 MM BEFORE VERIFICATION. THE SURGEON FELT ACCURATE AFTER REGISTRATION WITH AN ERROR METRIC OF 2.1. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8326974 ↗
• MalfunctionJan 4, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE SURGEON WAS HAVING DIFFICULTY VERIFYING ONE OF THEIR STRAIGHT SUCTIONS. IT HAD A DISTANCE TO DIVOT VALUE OF 3.0 THEY SWAPPED TO ANOTHER STRAIGHT SUCTION, AND THAT VERIFIED IMMEDIATELY. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME. AFTER THE CASE THE SURGEON TESTED THE TWO SUCTIONS. THE SUCTION THAT DID NOT VERIFY WAS NOW VERIFYING AND THE SUCTION THAT WAS VERIFYING WAS NOW RETURNING A DIVOT READING OF >3. THE REPORT IS ON THE FIRST SUCTION THAT WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001284. One submission often covers many models, so check the product and lot details in each record.

• Z-2317-2016 · Jul 18, 2016 · Terminated
  Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Syste
• Z-2319-2016 · Jul 18, 2016 · Terminated
  MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Sys
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
• Z-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• Z-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

…and 13 more.