N/A 9733533 (UDI 00643169702837)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169702837), received between Jun 5, 2018 and Jan 8, 2019 — classified as 2 malfunctions.

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

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

• MalfunctionJan 8, 2019Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SYSTEM BEGAN RECOGNIZING THE REGISTRATION PROBE WITH THE INSTRUMENT TRACKER AS A MICRODEBRIDER. THE MICRODEBRIDER WAS UNPLUGGED FROM THE SYSTEM BUT THE REGISTRATION PROBE WOULD NOT REVERIFY. THE SITE REBOOTED THE SYSTEM AND THE ISSUE STILL OCCURRED. THE SITE SWITCHED TO A FUSION SYSTEM AND THE SYSTEM STRUGGLED TO VERIFY THE REGISTRATION PROBE AND DID NOT TRACK WELL, THE SITE SWITCHED TO USE A STRAIGHT PROBE AND THE SITE WAS ABLE TO SUCCESSFULLY CONTINUE WITH THE PROCEDURE. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8228144 ↗
• MalfunctionJun 5, 2018Device Inoperable; Device Inoperable

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY WHILE VERIFYING INSTRUMENTS AND CAUSED A DELAY OF 5 MINUTES TO THE SURGERY. IT WAS REPORTED THAT THE SITE HAD A BAD INSTRUMENT TRACKER. THE SURGEON COMPLETED THE CASE WITHOUT NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7569419 ↗

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-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-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-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• 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-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1588-2014 · Apr 24, 2014 · Terminated
  MOUSE 9732721 STERILE O-ARM 10PK
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
• Z-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• Z-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK

…and 13 more.