StealthStation S8 Platform 9735667 (UDI 00763000272791)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000272791), received between Aug 27, 2020 and Feb 26, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Environmental Compatibility Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT LOADING THE SCAN ONTO THE USB AND IMPORTING WAS SUCCESSFUL AND WAS SUCCESSFUL FOR OTHER PATIENT SCANS. IT WAS NOTED THAT SCANS WOULD PERIODICALLY NOT TRANSFER TO THE NAVIGATION SYSTEM. THE CONFIGURATION OF THE NAVIGATION SYSTEM WAS NOT CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471544 ↗
• MalfunctionMay 23, 2023Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD BEEN HAVING ISSUES INTERMITTENTLY SHUTTING DOWN WHILE IN THE APPLICATION. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVED. THE SYSTEM WAS PLUGGED IN TO A KNOWN FUNCTIONAL PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986068 ↗
• MalfunctionMay 11, 2023Environmental Compatibility Problem; Environmental Compatibility Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TYPE OF PROCEDURE WAS A CRANIOTOMY. THERE WAS A MINIMAL (A FEW MINUTES) DELAY TO THE PROCEDURE. THOUGH SELF SHUTDOWN HAPPENED MULTIPLE TIMES AND THE SYSTEM EVENTUALLY DIED. THE MANUFACTURER REPRESENTATIVE SWAPPED IN THE OTHER NAVIGATION SYSTEM AND TRANSFERRED THE PATIENT FILE WHILE THE SIRE WAS NAVIGATING AND THERE WAS NO DELAY THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910828 ↗
• MalfunctionAug 11, 2022Device Sensing Problem; Material Integrity Problem; Mechanics Altered; Device Sensing Problem; Material Integrity Problem; Mechanics Altered

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS ALLEGEDLY LOOSE. IT WAS ALSO STATED THAT THE CAMERA COVER WAS WARPED. THE SYSTEM'S CAMERA COVER WAS BENT OUTWARDS. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. THE COVERS ON THE CAMERA AND MAIN CART WERE PARTIALLY OPENED, AND THE CAMERA HOLDER CLIP ON THE SAME CART WAS DAMAGED. THE CAMERAS ON BOTH NAVIGATIONS WERE LOOSE THEY WOULDN¿T HOLD POSITION IF TURNED VERTICALLY. THE CAMERA COVER WAS NOT BENT. THE COVERS ON THE CAMERA AND MAIN CARTS DIDN¿T LOOK DAMAGED ACCORDING TO THE MANUFACTURER REPRESENTATIVE (REP). THEY WERE PARTIALLY OPENED FROM WHAT THEY COULD SEE, THEY LOOKED LIKE SOMEONE TRIED TO OPEN THEM. HOWEVER; THE REP DID NOT OPEN THE CARTS TO CHECK AS THE SITE DIDN¿T HAVE A SERVICE CONTRACTS. THE CAMERA WAS STILL WORKING AS INTENDED AND WORKING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210527 ↗
• MalfunctionAug 27, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A PROCEDURE, THE ICONS ON THE TARGETING UNIT (TU) OF THE AUTOMATED TRAJECTORY GUIDANCE UNIT DISAPPEARED. IT WAS REPORTED THAT CONTROL UNIT (CU) DISPLAYED AN ERROR MESSAGE/WARNING THAT WERE NOT RECORDED BY THE USER. IT WAS REPORTED THAT THE CONNECTIONS TO THE CU AND TU WERE RESEATED WITHOUT RESOLUTION. REBOOTING THE CU RESTORED FUNCTIONALITY AS THE USER WAS ABLE TO HOME THE UNIT AND PROCEED WITH ALIGNMENT OF THE TU AND THE NEEDLE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. MEDTRONIC RECEIVED INFORMATION THAT ATTEMPTING TO RE-HOME THE UNIT DID NOT RESTORE FUNCTIONALITY AS THE UNIT WOULD NOT MOVE. A TU DISPLAYED AN EXCLAMATION POINT AND WAS NOT BLANK. MEDTRONIC RECEIVED INFORMATION THAT THE REPORTED ISSUE OCCURRED DURING A CRANIAL BIOPSY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF FIVE MINUTES DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10462677 ↗

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