NA 9733449Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000053369), received between Sep 4, 2018 and Feb 24, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 reports).

8 other recalls cover devices cleared under the same FDA submission (K153555); 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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT REGISTRATION WAS DIFFICULT ONLY FOR THE EM STRAIGHT SUCTION INSTRUMENTS. ALL OTHER EQUIPMENT COULD BE REGISTERED WITHOUT ANY ISSUES. THE SURGERY WAS COMPLETED USING THE NAVIGATION/IMAGE SYSTEM WITH OTHER EQUIPMENT. THIS ISSUE CAUSED NO SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433103 ↗
• MalfunctionNov 21, 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 THE STRAIGHT SUCTION WAS UNABLE TO TRACK CONSISTENTLY THROUGHOUT NAVIGATION WITH A FLAT EMITTER. IT WAS CONFIRMED THE THE ISSUE ONLY OCCURS WITH THE STRAIGHT SUCTION INSTRUMENT . THE ISSUE OCCURRED ACROSS DIFFERENT STRAIGHT SUCTIONS AND INSTRUMENT TRACKERS. THE INSTRUMENT COULD BE VERIFIED BUT HAD ISSUES TRACKING IN NAVIGATION UNTIL FURTHER ENTERED INTO THE SINUS . THERE WAS NO METAL INTERFERENCE. THE SITE PUT TOWELS BETWEEN THE EMITTER AND THE NON-METAL BED. THIS RESULTED IN A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617302 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION INSTRUMENT HAD DEFORMATION WHICH WAS CONFIRMED DURING THE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377969 ↗
• MalfunctionDec 27, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THIS SITE WAS HAVING ISSUES VERIFYING ALL THREE SUCTIONS. ALL OTHER INSTRUMENTS VERIFY WITHOUT ISSUE. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026227 ↗
• MalfunctionDec 26, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN INSTRUMENT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION WOULD NOT VERIFY FOR A CASE. THE SITE ENDED UP NOT USING THE INSTRUMENT IN A NAV CAPACITY FOR THE CASE. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019765 ↗
• MalfunctionJul 23, 2021Imprecision; Use of Device Problem; Imprecision; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BRING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE STRAIGHT SUCTION IS DAMAGED. IT WAS ABLE TO VERIFY FINE, BUT THEN THROUGHOUT THE CASE, THE STRAIGHTSHOT WAS NAVIGATING ACCURATELY, AND THE MANUFACTURER REPRESENTATIVE BELIEVED THAT THE SUCTION WAS OFF BY ABOUT 5 MM. THIS AMOUNT IS AN ESTIMATION BY THE REPRESENTATIVE. THE USERS DID NOT TRY TO ADJUST THE INSTRUMENT TRACKER AFTER THE INITIAL VERIFICATION AND THEY DID NOT TRY TO REVERIFY. THE PROBABLE CAUSE WAS SUSPECTED TO BE THAT THE INSTRUMENT TRACKER WAS BUMPED OR MOVED WHEN THE SURGEON WENT TO NAVIGATE SINCE THE OTHER INSTRUMENT WERE ACCURATE. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218648 ↗
• MalfunctionSep 23, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT INTRA-OPERATIVELY, IT WAS NOTICED THAT THE STRAIGHT SUCTION WAS DAMAGED. IT WAS REPORTED THAT THE STRAIGHT SUCTION VERIFIED AT THE BEGINNING OF THE CASE AND THAT DURING THE PROCEDURE, THE SUCTION TIP BROKE OFF. THE SITE GRABBED ANOTHER TRAY AND PULLED THE SUCTION FROM THERE TO MOVE FORWARD WITH THE CASE. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9105161 ↗
• MalfunctionSep 17, 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 WAS BENT. 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 9076291 ↗
• MalfunctionAug 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE STRAIGHT SUCTION INSTRUMENT BROKE IN HALF. THERE WAS LESS THAN A 1 HOUR DELAY TO THE SURGICAL TIME AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931276 ↗
• MalfunctionAug 26, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SUCTION WAS REPORTED TO HAVE BROKEN INTO TWO SEPARATE PIECES. IT WAS REPORTED THAT THE UNIT WAS DAMAGED AT THE HANDLE END OF THE UNIT. 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 Known Impact Or Consequence To Patient

  MAUDE report 8930417 ↗
• MalfunctionApr 25, 2019Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION DEVICES BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT ONE OF THE SITES STRAIGHT SUCTIONS HAD BEEN DRILLED ON AND WAS DAMAGED. THE SITE WAS ABLE TO VERIFY THE SUCTION BUT THEN HAD SOME ISSUES TRACKING IT. A CLINICAL SPECIALIST (CS) WAS UNABLE TO REPLICATE ANY TRACKING ISSUES AND SUSPECTED METAL INTERFERENCE DURING THE CLINICAL CASE. IT WAS NOTED THAT DURING THE CLINICAL CASE THE SURGEON PROCEEDED WITH THE SUCTION. THERE WERE 4 SCRATCHES ON THE TOP OF THE SUCTION, BUT THE SITE WAS NOT PURSUING A REPLACEMENT AT THE TIME OF REPORT. IT WAS ALSO NOTED THAT A SECOND STRAIGHT SUCTION WASN¿T VERIFYING EASILY AND WAS DIFFICULT. THE PROCEDURE WAS COMPLETED WITH NAVIGATION AND NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. TESTING REVEALED THAT THE SYSTEM WAS FUNCTIONING NORMALLY. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8551169 ↗
• MalfunctionApr 24, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT ONE OF THE STRAIGHT SUCTIONS ON SITE WAS BROKEN IN HALF. THE ACTUAL SUCTION CANNULA SEPARATED FROM THE HANDLE WHERE THE SUCTION AND TRACKER ATTACH. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8544928 ↗
• MalfunctionMar 28, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THE STRAIGHT SUCTION INSTRUMENT WAS BENT. THIS ISSUE OCCURRED DURING THE VERIFY INSTRUMENTS TASK. THE SITE CONTINUED TO USE THE SUCTION IN THE CASE. IT WAS NOTED THAT THE SITE GOT IT TO VERIFY, BUT IT WAS DIFFICULT TO VERIFY. THERE WAS NO DELAY DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS LATER REPORTED THAT IT WAS NOT KNOWN HOW THE SUCTION BECAME BENT. THE SITE DISCUSSED DURING THE CASE AND THEY WERE NOT POSITIVE IF IT WAS BENT. THEY WERE NOT SURE IF THE SUCTION/TRACKER WAS JUST OUTSIDE OF THE FLAT EMITTER FIELD. IT WAS NOTED THAT IT WORKED OKAY WHEN TESTED WITH ANOTHER NAVIGATION SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458802 ↗
• MalfunctionMar 11, 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 PREOPERATIVELY AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THE TIP OF THE STRAIGHT SUCTION WAS DEFORMED BEFORE THE PROCEDURE STARTED. THE STRAIGHT SUCTION WOULD HAVE PASSED VERIFICATION DESPITE THE DAMAGE. THE INSTRUMENT WAS NOT USED AND REPLACED WITH ANOTHER STRAIGHT 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 8410425 ↗
• MalfunctionJan 28, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE STRAIGHT SUCTION WOULD VERIFY INTERMITTENTLY. IT WAS NOTED THAT THE REPORTED ISSUE WAS CONFIRMED WITH A DEMO HEAD. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8281440 ↗
• MalfunctionDec 10, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING THE CASE THE STRAIGHT SUCTION WAS FOUND TO BE DAMAGED. A NEW SUCTION WAS USED TO COMPLETED THE PROCEDURE. THERE WAS NO SURGICAL DELAY DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145467 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT STRAIGHT SUCTION WAS NOT FULLY SEATED IN THE TRAY. IT WAS TESTED AND IT COULDN¿T BE VERIFIED. IT VERIFIED ONCE AFTER ABOUT A MINUTE AND IT WAS ABOUT 3MM OFF. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7885464 ↗
• MalfunctionSep 4, 2018Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SURGEON DID NOT FEEL VERY ACCURATE AFTER VERIFYING THE STRAIGHT SUCTION AT 1.9 MM. THERE WAS NO IMPACT TO PATIENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841716 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153555. One submission often covers many models, so check the product and lot details in each record.

• Z-3058-2017 · Jun 29, 2017 · Terminated
  Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Sucti
• Z-3053-2017 · Jun 29, 2017 · Terminated
  Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of re
• Z-3054-2017 · Jun 29, 2017 · Terminated
  Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reus
• Z-3052-2017 · Jun 29, 2017 · Terminated
  Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reu
• Z-3056-2017 · Jun 29, 2017 · Terminated
  Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg
• Z-3051-2017 · Jun 29, 2017 · Terminated
  Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reus
• Z-3055-2017 · Jun 29, 2017 · Terminated
  Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg C
• Z-3057-2017 · Jun 29, 2017 · Terminated
  Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc.,