N/A 9734306Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000054120), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Mechanical 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 ORANGE AND PURPLE INSTRUMENTS HAD DISTORTIONS THAT RESULTED IN POOR NAVIGATION RECOGNITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751279 ↗

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-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-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-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-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-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-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-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