NDI Passive Sphere 8801074Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00805832070029), received between Aug 3, 2022 and May 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (1 report).

25 other recalls cover devices cleared under the same FDA submission (K033621); 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.

• MalfunctionMay 23, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE DISPOSABLE SPHERE HAD THE REFLECTIVE COATING FALLING OFF THE BALL. THE ISSUE OCCURRED PRE-INCISION. NO KNOWN IMPACT TO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080370 ↗
• MalfunctionAug 3, 2022Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A HAIR WITHIN THE STERILE PACKAGING OF THE SPHERES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033621. One submission often covers many models, so check the product and lot details in each record.

• Z-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1585-2014 · Apr 24, 2014 · Terminated
  INST 9731132 KIT CR REF FRAME DRIVER 5PK
• 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-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• 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

…and 10 more.