N/A 9731203Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074240091), received between Jun 2, 2019 and Jun 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED IN SERVICING. IT WAS REPORTED THAT INSTRUMENTS COULD NOT BE REGISTERED, THE CAMERA WAS NOT WORKING. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8661294 ↗

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-1588-2014 · Apr 24, 2014 · Terminated
  MOUSE 9732721 STERILE O-ARM 10PK
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1581-2014 · Apr 24, 2014 · Terminated
  DISP 9730950 STRL SPHERE, 1 PK INSERT
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• Z-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

…and 13 more.