N/A 9733450 (UDI 00613994378477)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994378477), received between Dec 15, 2016 and Apr 21, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY WAS 0.2MM OR LESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875320 ↗
• 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 21026241 ↗
• MalfunctionDec 13, 2024Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENTS COULD NO LONGER BE REFERENCED. IT WAS NOTED THAT THEY WERE "PROBABLY BENT." THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926439 ↗
• MalfunctionJun 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE 70 DEGREE SUCTION WAS BENT BY THE HEALTH CARE PROFESSIONAL INSIDE OF THE PATIENT ANATOMY. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704100 ↗
• MalfunctionJun 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A DAMAGED STRAIGHT SUCTION WAS RECEIVED IN MATERIALS. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8702692 ↗
• 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 8698251 ↗
• MalfunctionMar 25, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE CURVED SUCTION WAS DAMAGED AS THE INSTRUMENT WOULD RETURN A HIGH DISTANCE TO DIVOT VALUE, >2.0MM, WHEN VERIFYING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8448465 ↗
• MalfunctionDec 6, 2018Material 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 SITE'S CURVED SUCTION INSTRUMENT WAS FOUND TO BE DAMAGED DURING THE CASE. THE SITE USED ANOTHER INSTRUMENT TO COMPLETE THE SURGERY. 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 8137250 ↗
• MalfunctionJan 4, 2018Communication or Transmission Problem; Device Operates Differently Than Expected; Material Integrity Problem; Communication or Transmission Problem; Device Operates Differently Than Expected; Material Integrity Problem

  A SITE REPRESENTATIVE REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), A 70 DEGREE CURVED SUCTION COULD NOT BE RECOGNIZED. A BACK UP SUCTION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME. AFTER PROCEDURE, A SITE REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7165460 ↗
• MalfunctionOct 12, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), A 70 DEGREE SUCTION WAS DIFFICULT TO VERIFY. SURGEON WAS ABLE TO GET THE INSTRUMENT TO VERIFY BY MANIPULATING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6945456 ↗
• MalfunctionJun 23, 2017Communication or Transmission Problem; Device Operates Differently Than Expected; Communication or Transmission Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SITE WAS UNABLE TO TRACK THE 70 DEGREE SUCTION. IT WAS REPORTED THAT THE INSTRUMENT COULD BE SEEN IN THE FIELD OF VIEW, BUT NAVIGATION WAS NOT POSSIBLE. WHEN ATTEMPTING TO RE-VERIFY, THE DIVOT ERROR WAS TOO HIGH AND THE INSTRUMENT WOULD NOT COMPLETE THE VERIFICATION. ALL OTHER INSTRUMENTS COULD BE VERIFIED AND THE EMITTER WAS PROPERLY PLACED. THE SITE ELECTED TO USE A SEPARATE SUCTION TO COMPLETE THE PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6663086 ↗
• MalfunctionJun 16, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE INSTRUMENT TRACKER WOULD NO LONGER REMAIN ON A 70 DEGREE SUCTION. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6646960 ↗
• MalfunctionMay 25, 2017Material Deformation; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE CURVED SUCTION BECAME BENT. THE SITE ELECTED TO CONTINUE USING THE SUCTION IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591177 ↗
• MalfunctionApr 5, 2017Break; Material Deformation; Break; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE (B)(6) DEGREE CURVED SUCTION INSTRUMENT WAS DAMAGED. THE SURGEON CONTINUED THE SURGERY USING ANOTHER INSTRUMENT. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461787 ↗
• MalfunctionMar 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A SITE REPRESENTATIVE REPORTED THAT THE CURVED SUCTION WAS BENT BUT IT WAS STILL POSSIBLE TO VERIFY IT WHEN PUSHING/PRESSING IT INTO THE DIVOT. NO PATIENT WAS PRESENT DURING THE TIME OF THE REPORTED INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 6446379 ↗
• MalfunctionDec 15, 2016Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE SURGEON ALLEGED AN INACCURACY OCCURRED. THE SURGEON ALLEGED A 4 MILLIMETER INACCURACY WITH THE CURVED 70 DEGREE SUCTION. ALL OTHER INSTRUMENTS WERE ACCURATE WITHIN 0.5 MILLIMETERS. SUCTION VERIFIED WITH NO ISSUE, HOWEVER, THE SURGEON DEEMED BEING INACCURATE USING THEM. THE DOCTOR STOPPED USING THESE INSTRUMENTS AND CONTINUED THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6175743 ↗

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-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• 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
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• 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-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE

…and 13 more.