N/A 9733450 (UDI 00763000053390)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000053390), received between Sep 19, 2018 and Jul 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Imprecision” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SUSPECTED AND MOST LIKELY CAUSE OF THE REPORTED ISSUE WAS BELIEVED TO BE DETERIORATION OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556008 ↗
• MalfunctionSep 4, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT WAS MAKING AN "UNUSUAL NOISE." NO FURTHER INFORMATION COULD BE PROVIDED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135706 ↗
• MalfunctionSep 19, 2018Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE ISSUE OCCURRED INTRAOPERATIVELY WHILE VERIFYING INSTRUMENTS AND DELAYED THE SURGERY BY LESS THAN ONE HOUR. IT WAS REPORTED THAT THERE WAS DIFFICULTY REGISTERING THE 70-DEGREE SUCTION. THE SUCTION DID EVENTUALLY GET REGISTERED AND IT WAS THE ONLY INSTRUMENT SHOWING INACCURATE. 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 7891845 ↗

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-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-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-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-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-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-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-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