StealthStation S8 Platform 9735667 (UDI 00763000359782)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00763000359782), received between Feb 14, 2022 and Sep 30, 2026 — classified as 1 death, 3 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 reports).

2 other recalls cover devices cleared under the same FDA submission (K162309); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Medtronic received information regarding a Navigation system being used outside of a procedure. It was reported that an inaccuracy was experienced while working with 2 different instruments in the same case. The application team found that the issue was with the end user (human issue). After that they verified the accuracy using demo sample. It was reported that all instruments were accurate and that the issue was with the end user. The amount of the inaccuracy was 10 mm, but it was not because of equipment or instrument. As per application team, it was user mistake. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945788 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926126 ↗
• MalfunctionSep 24, 2026Device Sensing Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889462 ↗
• MalfunctionJun 29, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA CART WAS NOT WORKING, OR THERE WAS A BLANK SCREEN AFTER SWITCHING ON THE EQUIPMENT. THE SCREEN WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659910 ↗
• MalfunctionApr 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THERE WAS A NAVIGATION INACCURACY. IT WAS REPORTED THAT THE ISSUE OCCURRED INTRA-OPERATIVELY DURING AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. THERE WAS A PARALLEL INACCURACY OF 4 MM. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT THE AUTOMATED TRAJECTORY GUIDANCE UNIT TRACKER AND A POINTER WERE USED. THE INACCURACY WAS VERIFIED BY MERGE POST-OPERATIVELY AFTER IMPLANTATION RESULT WITH INITIAL PLAN. THE ANATOMICAL MARKS WERE ACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831865 ↗
• MalfunctionJan 23, 2026Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WOULD SOMETIMES SEE INSTRUMENTS POORLY. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE OCCURRED ON 2025-DEC-20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163392 ↗
• MalfunctionDec 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE POWER CORD HAD POOR CONTACT. THE SYSTEM HAD TWO MONITORS, SO WHEN ONE MONITOR HAS PROBLEM THE SITE USED A SECOND ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791137 ↗
• MalfunctionNov 13, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS INTERMITTENTLY NOT ABLE TO DETECT THE INSTRUMENTS. DURING TROUBLESHOOTING, THE CUSTOMER REPORTED ISSUE WAS NOT FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542134 ↗
• MalfunctionNov 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE AMOUNT OF INACCURACY OBSERVED WITH THE MICROSCOPE WAS 3 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523710 ↗
• MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT A DISCREPANCY OF 1-2MM WAS OBSERVED. NEUROSURGEONS OBSERVED A SPATIAL DISCREPANCY BETWEEN THE IMAGE FROM THE AMPLIFIER AND THE PROJECTION OF THE NEURONAVIGATION SYSTEM IN USE. THE INSTRUMENT IN USE WAS SUPPOSED TO BE A 1.5 INCH ROUND-TIPPED PASSIVE PLANAR PROBE WITH A STEALTHAIR SPINAL FRAME OR SMALL PASSIVE FRAME. THERE SEEMED TO BE A DEPTH DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464277 ↗
• MalfunctionOct 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY AMOUNT WAS UNKNOWN. EVENT CONTEXT AND FURTHER INFORMATION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437869 ↗
• MalfunctionSep 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE HAS FACED ISSUE IN MULTIPLE LONG SEGMENT SPINE FIXATION CASES. INACCURACY WERE FACED IN CASES PERFORMED ON (B)(6). ALL OF THESE WERE CASES WHERE FIXATION WAS FOR MORE THAN 2/3 LEVELS. THERE WAS APPROXIMATELY 5MM IN INFERIOR AND SUPERIOR DIRECTIONS; GROSS INACCURACY IN MEDIAL AND LATERAL DIRECTIONS. THE CLINICAL WORKFLOW FOR L1-L5/S1 PROCEDURES WERE AS FOLLOWS: THE NAVIGATION SYSTEM WAS POSITION ON THE CAUDAL END. THERE WAS ADEQUATE EXPOSURE OF L1-S1 LEVELS. SHORT CLAMP AND STEALTHAIR REFERENCE FRAME ON S1 SPINOUS PROCESS. THE CLAMP HELD THE SPINOUS PROCESS SNUGGLY. THEY CHECKED FOR SERRATIONS ON THE CLAMP AND THE APPEARED TO BE SHARP ENOUGH TO HOLD THE SPINOUS PROCESS. THERE WAS A LOW DOSE OR STANDARD 3D SPIN WAS TAKEN WITH A PATIENT IN APNEA. IMMEDIATELY POST THE 3D SPIN, THE SURGEON STARTED WITH SCREWS. THEY USED THE ORANGE AND GREY NAVLOCKS WITH AWL SHARP, THORACIC PROBE, 4.5MM LEGACY CANNULATED TAP FOLLOWED BY SCREWS. THEY HAVE OBSERVED THE CASE WITH THE SAME WORKFLOW. IMMEDIATELY AFTER THE SPIN THEY ASKED THE SURGEON TO CHECK THE ACCURACY AT EACH LEVEL. THEY USED ALL THREE INSTRUMENTS TO CHECK THE ACCURACY. AT L1-L2 LEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982449 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE HAS FACED ISSUE IN MULTIPLE LONG SEGMENT SPINE FIXATION CASES. INACCURACY WERE FACED IN CASES PERFORMED ON (B)(6). ALL OF THESE WERE CASES WHERE FIXATION WAS FOR MORE THAN 2/3 LEVELS. THERE WAS APPROXIMATELY 5MM IN INFERIOR AND SUPERIOR DIRECTIONS, GROSS INACCURACY IN MEDIAL AND LATERAL DIRECTIONS. THE CLINICAL WORKFLOW FOR L1-L5/S1 PROCEDURES WERE AS FOLLOWS: THE NAVIGATION SYSTEM WAS POSITION ON THE CAUDAL END. THERE WAS ADEQUATE EXPOSURE OF L1-S1 LEVELS. SHORT CLAMP AND STEALTHAIR REFERENCE FRAME ON S1 SPINOUS PROCESS. THE CLAMP HELD THE SPINOUS PROCESS SNUGGLY. THEY CHECKED FOR SERRATIONS ON THE CLAMP AND THE APPEARED TO BE SHARP ENOUGH TO HOLD THE SPINOUS PROCESS. THERE WAS A LOW DOSE OR STANDARD 3D SPIN WAS TAKEN WITH A PATIENT IN APNEA. IMMEDIATELY POST THE 3D SPIN, THE SURGEON STARTED WITH SCREWS. THEY USED THE ORANGE AND GREY NAVLOCKS WITH AWL SHARP, THORACIC PROBE, 4.5MM LEGACY CANNULATED TAP FOLLOWED BY SCREWS. THEY HAVE OBSERVED THE CASE WITH THE SAME WORKFLOW. IMMEDIATELY AFTER THE SPIN THEY ASKED THE SURGEON TO CHECK THE ACCURACY AT EACH LEVEL. THEY USED ALL THREE INSTRUMENTS TO CHECK THE ACCURACY. AT L1-L2 LEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882579 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE HAS FACED ISSUE IN MULTIPLE LONG SEGMENT SPINE FIXATION CASES. INACCURACY WERE FACED IN CASES PERFORMED ON 31ST JULY, 1ST AUGUST, 8TH AUGUST, 12TH AUGUST. ALL OF THESE WERE CASES WHERE FIXATION WAS FOR MORE THAN 2/3 LEVELS. THERE WAS APPROXIMATELY 5MM IN INFERIOR AND SUPERIOR DIRECTIONS, GROSS INACCURACY IN MEDIAL AND LATERAL DIRECTIONS. THE CLINICAL WORKFLOW FOR L1-L5/S1 PROCEDURES WERE AS FOLLOWS: THE NAVIGATION SYSTEM WAS POSITION ON THE CAUDAL END. THERE WAS ADEQUATE EXPOSURE OF L1-S1 LEVELS. SHORT CLAMP AND STEALTHAIR REFERENCE FRAME ON S1 SPINOUS PROCESS. THE CLAMP HELD THE SPINOUS PROCESS SNUGGLY. THEY CHECKED FOR SERRATIONS ON THE CLAMP AND THE APPEARED TO BE SHARP ENOUGH TO HOLD THE SPINOUS PROCESS. THERE WAS A LOW DOSE OR STANDARD 3D SPIN WAS TAKEN WITH A PATIENT IN APNEA. IMMEDIATELY POST THE 3D SPIN, THE SURGEON STARTED WITH SCREWS. THEY USED THE ORANGE AND GREY NAVLOCKS WITH AWL SHARP, THORACIC PROBE, 4.5MM LEGACY CANNULATED TAP FOLLOWED BY SCREWS. THEY HAVE OBSERVED THE CASE WITH THE SAME WORKFLOW. IMMEDIATELY AFTER THE SPIN THEY ASKED THE SURGEON TO CHECK THE ACCURACY AT EACH LEVEL. THEY USED ALL THREE INSTRUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882502 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THERE WAS AN INACCURACY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882463 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THERE WAS AN INACCURACY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882443 ↗
• MalfunctionAug 13, 2025Incorrect, 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 THERE WAS AN ACCURACY ISSUE WHILE USING THE NAVIGATION SYSTEM WITH A C-ARM. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS 2MM DIFFERENCE FROM THE ACTUAL POINT. THE PROBABLE CAUSE WAS LIKELY DUE TO THE TRACKER MOVING A BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800691 ↗
• MalfunctionJul 31, 2025Device Sensing Problem; Device Sensing Problem

  "FAILED TO DETECT BALLS¿ INDICATED THE SITE WAS NEVER ABLE TO DETECT/TRACK VERSUS THERE BEING INTERMITTENT TRACKING. AS SUCH, THIS MET THE NOT REPORTABLE CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676222 ↗
• MalfunctionJul 1, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A 'LOCALIZER FAULTED' WAS SHOWING ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370968 ↗
• MalfunctionJun 27, 2025Mechanical Problem; Application Program Problem; Connection Problem; Mechanical Problem; Application Program Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A 'LOCALIZER FAULTED' ERROR APPEARED ON THE DISPLAY, FOLLOWED BY A LOCALIZER NOT CONNECTED ERROR. THE LOCALIZER WAS FOUND TO BE FAULTY AND REQUIRED REPLACEMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346931 ↗
• MalfunctionJun 16, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE C-ARM TRACKER WAS NOT TURNING ON. THE TRACKER WAS REPLACED WITH NEW BATTERIES, AND IT WAS CROSS-VERIFIED THAT THE TRACKER STILL DID NOT TURN ON. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214005 ↗
• MalfunctionJun 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE AMOUNT OF THE INACCURACY WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166686 ↗
• MalfunctionMay 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) TRANSMISSION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088923 ↗
• MalfunctionMay 27, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING PRECHECK OF THE SYSTEM, THE SYSTEM SHOWED LOCALIZER FAULTED IN THE OPTICAL SOFTWARE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088784 ↗
• MalfunctionMar 31, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA CART MONITOR WAS TURNING OFF INTERMITTENTLY, ALTHOUGH THE CAMERA CONTINUED TO FUNCTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731492 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2024 · Mar 26, 2024 · Open, Classified
  Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
• Z-1995-2020 · Aug 9, 2019 · Terminated
  Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen