N/A 9733447XOMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994306821), received between Jun 12, 2019 and Jun 12, 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 18, 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 12, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH TRACKING THE PASSIVE PLANAR INSTRUMENT ONLY. THERE WERE NO ISSUES WITH ANY OTHER INSTRUMENTS. THERE WAS A 10 MINUTE DELAY BEFORE THE SIT DECIDED TO ABORT NAVIGATION. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8691752 ↗

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-1583-2014 · Apr 24, 2014 · Terminated
  DRAPE 9732722 TUBE STERILE O-ARM 20PK
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• 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-1581-2014 · Apr 24, 2014 · Terminated
  DISP 9730950 STRL SPHERE, 1 PK INSERT
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE
• Z-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK

…and 13 more.