N/A 9733448 (UDI 00613994378484)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994378484), received between Oct 22, 2018 and Jan 23, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SEEKER WAS DIFFICULT TO VERIFY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21224633 ↗
• MalfunctionNov 1, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD TWO BENT OSTIUM SEEKERS. NO PATIENT INVOLVEMENT WAS REPORTED. THE DAMAGED COULD HAVE BEEN DUE TO CONTINUED USE OR WHEN THEY WERE STERILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588419 ↗
• MalfunctionJul 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT HAD NO ACCURACY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730727 ↗
• MalfunctionMar 5, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE OSTIUM PROBE¿S TIP WAS BENT DURING SHIPPING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8390726 ↗
• MalfunctionOct 22, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE PERFORMING A PLANNED MAINTENANCE (PM), THE OSTIUM SEEKER WAS REPORTED TO BE BENT AND RETURNING A DIVOT ERROR BETWEEN 2 TO 2.6 IN THE APPLICATION SOFTWARE OF THE NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7990580 ↗

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-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1585-2014 · Apr 24, 2014 · Terminated
  INST 9731132 KIT CR REF FRAME DRIVER 5PK
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
• Z-1581-2014 · Apr 24, 2014 · Terminated
  DISP 9730950 STRL SPHERE, 1 PK INSERT
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT

…and 13 more.