NDI Passive Sphere 8801071Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00805832070012), received between Jul 17, 2023 and Jul 18, 2023 — classified as 1 injury, 1 malfunction.

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

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.

• MalfunctionJul 18, 2023Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE USED THE BAGS OF SPHERES TO CLEAR STOCK FOR NAVIGATION. THE NAVIGATION DID NOT RECOGNIZE THE INSTRUMENTS. AN INACCURACY OCCURRED. THERE WAS AN INCREASED INTERVENTION TIME TO FIND AND REMEDY THE PROBLEM. THE USE OF NAVIGATION WAS ABORTED. THE SURGERY WAS DISCONTINUED. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342914 ↗
• InjuryJul 17, 2023Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE USED THE BAGS OF SPHERES TO CLEAR STOCK FOR NAVIGATION. THE NAVIGATION DID NOT RECOGNIZE THE INSTRUMENTS. AN INACCURACY OCCURRED. THERE WAS AN INCREASED INTERVENTION TIME TO FIND AND REMEDY THE PROBLEM. THE USE OF NAVIGATION WAS ABORTED. THE SURGERY WAS DISCONTINUED. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334478 ↗

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-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• 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-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
• Z-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1595-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801071 1/TRAY 12PK
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• 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

…and 10 more.