NDI Passive Spheres 8800738Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00805832040022), received between May 28, 2025 and May 28, 2025 — classified as 1 malfunction.

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

• MalfunctionMay 28, 2025Failure to Sense; Failure to Sense

  INITIAL REPORT: ON APRIL 08, 2025, NDI'S SPHERE DISTRIBUTOR, AMPLITUDE, RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL IN FRANCE, ALLEGING THAT NDI'S SENSORS (SPHERES) RETURNED A STROBE-LIKE IMAGE TO THEIR TRACKING SYSTEM, THEREBY MAKING IT IMPOSSIBLE TO VALIDATE THE VARIOUS NAVIGATION PHASES. DUE TO THIS ISSUE, THE SURGICAL TEAM DETERMINED THAT IT WAS IMPOSSIBLE TO PROGRESS THROUGH THE VARIOUS OPERATING STAGES OF THE PLANNED SURGERY. THIS RESULTED IN A 35 MINUTE DELAY IN THE SURGERY. THE SURGICAL TEAM WAS ABLE TO RESOLVE THE ISSUE BY USING SENSORS FROM ANOTHER COMPANY. IT WAS REPORTED THAT THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095203 ↗

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-1584-2014 · Apr 24, 2014 · Terminated
  ENT PRGM 9734636 ADD FUSION NAV AxiEM
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR
• Z-1593-2014 · Apr 24, 2014 · Terminated
  PIN, 9733236, 150MM, STERILE, PERC REF
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1590-2014 · Apr 24, 2014 · Terminated
  PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
• 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-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1602-2014 · Apr 24, 2014 · Terminated
  UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE

…and 10 more.