StealthStation S8 Platform 9735667 (UDI 00763000359799)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000359799), received between Apr 15, 2022 and Aug 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 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 WHEN BOOTING THE SYSTEM, A SERIES OF BOOT SEQUENCES FAILED PREVENTING IT FROM LOADING THE LOGIN SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967324 ↗
• MalfunctionSep 20, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS INTEGRATING NAVIGATION SYSTEM WITH AN ORBIC C ARM. THEY WERE UNABLE TO START THE CALIBRATION PROCESS AS THE CAMERA WAS NOT ABLE TO DETECT THE WIRELESS TRACKER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454179 ↗
• MalfunctionApr 15, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE CAMERA WAS DAMAGED. THE CAMERA FELL FROM THE CAMERA ARM. CAUSING THE LASER HANDLE TO BECOME DAMAGED. IT WAS UNKNOWN IF THE CAMERA FUNCTIONALITY WAS IMPACTED. THE SITE STATED THAT THE CAMERA MOUNT ONLY HAD TWO SCREWS INSTALLED RATHER THAN THE FOUR. TROUBLESHOOTING WAS PERFORMED AND TECHNICAL SERVICES RECOMMENDED DOING "NDI TOOLBOX TESTING" PRIOR TO USAGE. THE NEXT STEP WAS FOR THE CAMERA HANDLE CLIP TO BE REPLACED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117841 ↗

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