StealthStation S8 9735665Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000359874), received between Oct 25, 2022 and May 13, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE INTERFACE BOX WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009209 ↗
• MalfunctionApr 1, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA INDICATOR LIGHT WAS ABNORMAL. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE CAMERA AMBER LIGHT EMITTING DIODE (LED) STAYED ON. THE FAULT LIGHT WAS ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748019 ↗
• MalfunctionMar 6, 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 SECONDARY SCREEN WAS NOT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536007 ↗
• MalfunctionFeb 7, 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 A BLACK SCREEN OCCURRED OCCASIONALLY WHEN THE SYSTEM WAS RUNNING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333292 ↗
• MalfunctionOct 10, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE OPTICAL LOCALIZER COULD NOT WORK. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415892 ↗
• MalfunctionAug 9, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM COULD NOT BOOT UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948832 ↗
• MalfunctionMay 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT MERGE NAVIGATION BLACK SCREEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS A BLACK SCREEN AFTER A NAVIGATION MERGE WAS PERFORMED AND EVEN WHEN A NEW CASE WAS EXPORTED, IT WAS BLACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341692 ↗
• MalfunctionApr 8, 2024Display 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 MONITOR COULDN'T DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061699 ↗
• MalfunctionJul 13, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE A PROCEDURE. IT WAS REPORTED AN ERROR DISPLAYED WITH IMAGE COMPOSITING. NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED CAUSE OF THE ISSUE WAS POTENTIALLY THE PATIENT IMAGES NOT BEING OPTIMAL FOR THE NAVIGATION SYSTEM OR THERE WAS TOO MUCH MODEL. ADDITIONAL INFORMATION WAS RECEIVED. THE SCAN INFORMATION WAS SPACING:0.5,THICKNESS:1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313661 ↗
• MalfunctionMar 28, 2023Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE AXIEM SYSTEM COULD NOT CONNECT. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629351 ↗
• MalfunctionOct 25, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE AXIEM SYSTEM COULD NOT WORK. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666530 ↗

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