N/A 9733451 (UDI 00763000053383)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000053383), received between Apr 30, 2019 and Aug 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 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 THAT THE CURVED SUCTION WAS NOT RECOGNIZED. 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 22890542 ↗
• MalfunctionApr 30, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING THE VERIFY INSTRUMENTS TASK OF A FESS PROCEDURE THEY WERE HAVING TROUBLE VERIFYING SOME OF THEIR INSTRUMENTS. THEY TRIED TWO DIFFERENT TRAYS, AND SOME OF THE INSTRUMENTS WERE NOT VERIFYING PROPERLY, WHILE OTHERS (SUCH AS THE STRAIGHT SUCTION) VERIFIED WITH NO TROUBLE. THE SITE MENTIONED THE 90 DEGREE SUCTION AND OSTIUM SEEKER, BUT THERE WERE OTHERS WITH PROBLEMS AS WELL. THE SITE CHECKED METAL INTERFERENCE VALUES, AND THEY WERE LESS THAN 1.0. THE SITE CONTINUED WITH INSTRUMENTS THAT THEY COULD VERIFY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED: THE TWO INSTRUMENTS INVOLVED WERE THE 90 DEGREE SUCTION AND THE 70 DEGREE SUCTION. THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE TIPS OF THE INSTRUMENTS LOOKED BENT AND THERE WAS DIFFICULTY VERIFYING THE INSTRUMENTS. THE INSTRUMENTS EVENTUALLY VERIFIED. THE REP STATED HE WAS TOLD THAT THE INSTRUMENTS WOULD NOT VERIFY PROPERLY. THE REP STATED THAT WHEN HE WENT TO CHECK THE INSTRUMENTS THEY LOOKED BENT BUT WERE NOT BENT ENOUGH TO BE CONSIDERED DAMAG

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8564535 ↗

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-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-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-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-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-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-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.,
• 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-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