NDI Passive Sphere 8801075Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00805832070036), received between Jun 11, 2019 and Oct 31, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT RECOGNITION WAS POOR, MAKING IT DIFFICULT TO PASS VERIFICATION. ADDITIONALLY, THE ACCURACY WAS LOW. IT WAS NOTED THAT THE INACCURACY WAS CAUSED BY ALL THE INSTRUMENTS. A DIFFERENT PASSIVE MARKER WAS OPENED AND USED. THERE WAS NO DELAY, AND NO REPORTED PATIENT IMPACT. IT WAS REPORTED THAT THE INACCURACY WAS "A FEW" MILLIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441816 ↗
• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  (B)(6) 2023 (B)(6) (REP HCP FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO CLOSE THE SURGICAL INCISION, THE GREY PORTION OF THE NAVIGATION SPHERE CAME OFF IN THE DOME AND REMAINED IN THE OPERATIVE FIELD. WHEN THE INSTRUMENT WAS CHECKED THE NAVIGATOR SPHERE WAS FOUND WITH THE HALF GREY PORTION MISSING. THE DEVICE WAS FOUND AND DID NOT REMAIN IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979769 ↗
• MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY WAS "A FEW" MILLIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962964 ↗
• MalfunctionApr 22, 2025Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE REFLECTIVE MATERIAL OF THE NAVIGATION SPHERES WERE FALLING OFF. IT WAS UNKNOWN IF THERE WAS PATIENT IMPACT, AND IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883321 ↗
• MalfunctionAug 15, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SPHERES WERE NOT RECOGNIZED BY NAVIGATION. THE INCIDENT TOOK PLACE IN THE NEUROSURGERY UNIT. THERE WAS NO CLINICAL CONSEQUENCE. IT WAS CONFIRMED THAT THE ISSUE WAS DURING TRACKING AFTER THE INSTRUMENT PASSED VERIFICATION. DELAY IN SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992705 ↗
• MalfunctionOct 12, 2023Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO CLOSE THE SURGICAL INCISION, THE GREY PORTION OF THE NAVIGATION SPHERE CAME OFF IN THE DOME AND REMAINED IN THE OPERATIVE FIELD. WHEN THE INSTRUMENT WAS CHECKED THE NAVIGATOR SPHERE WAS FOUND WITH THE HALF GREY PORTION MISSING. THE DEVICE WAS FOUND AND DID NOT REMAIN IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922744 ↗
• MalfunctionOct 19, 2022Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY. IT WAS REPORTED THAT WHEN THE REGISTRATION PROBE WAS PUT INTO THE DIVOT OF THE PATIENT TRACKER, THE DISTANCE TO DIVOT SHOWED 4.3 TO 4.5 MILLIMETERS OFF. HOWEVER, WHEN THE REGISTRATION PROBE WAS PLACED SUPERIORITY OF THE DIVOT OPENING BY ROUGHLY 1 MILLIMETER THE DISTANCE TO DIVOT WAS 1 MILLIMETER AND THE MACHINE RECOGNIZED THE INSTRUMENT. THE DOCTOR WENT AHEAD WITH THE SURGERY AND EVERY TIME HE NEEDED TO REGISTER AN INSTRUMENT HE WOULD PUT IT IN THE SAME LOCATION AS HE PUT THE REGISTRATION PROBE TO REGISTER THE INSTRUMENT. WHEN HE GOT INSIDE AND DID THE ACTUAL SURGERY HE WAS VERY ACCURATE. THERE WAS A DELAY OF 15 MINUTES AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632772 ↗
• MalfunctionNov 11, 2020Imprecision; Device Sensing Problem; Imprecision; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT HAD RECOGNITION FAILURE RIGHT AFTER THE NAVIGATION SYSTEM WAS USED SO THE PASSIVE MARKER WAS SUSPECTED AND IT WAS REPLACED AND WIPED SEVERAL TIMES. THE RECOGNITION FAILURE PERSISTED. WHEN THE INSTRUMENT WAS RECOGNIZED AFTER CORRESPONDENCE WAS PERFORMED SEVERAL TIMES, THE REFERENCE WAS MISALIGNED AND THERE WAS NO ACCURACY/THE ACCURACY OF THE NAVIGATION SYSTEM DID NOT MATCH SO THE USE OF THE NAVIGATION SYSTEM WAS DISCONTINUED. IT WAS NOTED THAT THE ACCURACY OF THE NAVIGATION SYSTEM WAS HIGH, BUT THE INSTRUMENT DID NOT RESPOND, SO THEY DID NOT TRY USING THE NAVIGATION SYSTEM AS IT WAS FASTER TO CONFIRM VISUALLY. THE PHYSICIAN WAS UNHAPPY WITH THIS, AND SUSPECTED A DEFECTIVE PRODUCT WAS USED. THE PROCEDURE ITSELF WAS ABLE TO BE COMPLETED SUCCESSFULLY. IT WAS NOTED THAT AFTER THE PROCEDURE THE PASSIVE MARKER WAS CHECKED AND IT WAS POSSIBLE THAT THERE WAS BONE WAX ADHERED ON ALL THE PASSIVE MARKERS USED IN THIS CASE. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10824028 ↗
• MalfunctionNov 27, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE WAS DOING A FINAL COUNT TO THEIR INSTRUMENTS USED DURING A PROCEDURE, THEY DISCOVERED THAT ONE OF THE SPHERES WAS DAMAGED AND SPLIT IN HALF. THE OTHER HALF OF THE SPHERE WAS LOCATED ON THE SURGICAL DRAPE. THE SPHERE WAS DISCARDED AND IS NOT AVAILABLE TO BE SENT IN. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DAMAGE TO THE SPHERES DID NOT OCCUR INSIDE OF THE PATIENT ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9383739 ↗
• MalfunctionJun 11, 2019Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT PRE-OPERATIVELY, IT WAS FOUND THAT THERE WAS A BLACK HAIR ADHERED IN THE PACKET SEAL. THERE WAS NO PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8688748 ↗

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-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• Z-1599-2014 · Apr 24, 2014 · Terminated
  TUMOR RES. PACK 9733553 AxiEM S.M.
• Z-1581-2014 · Apr 24, 2014 · Terminated
  DISP 9730950 STRL SPHERE, 1 PK INSERT
• 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-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1588-2014 · Apr 24, 2014 · Terminated
  MOUSE 9732721 STERILE O-ARM 10PK
• Z-1601-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733608 SKULL MOUNT
• Z-1596-2014 · Apr 24, 2014 · Terminated
  SPHERES 8801075 5/TRAY 12PK
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT

…and 10 more.