Stealthstation® S7™ 9734685 (UDI 00643169505827)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169505827), received between Nov 5, 2018 and Oct 20, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE ISSUE WAS NOT WITH THE POINTER, THE PROBLEM WAS PROBABLY DUE TO AN INCORRECT REGISTRATION METHOD. THE EVENT OCCURRED DURING EITHER A BIOPSY OR TUMOR RESECTION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337064 ↗
• MalfunctionJun 11, 2025Failure to Power Up; Excessive Heating; Application Program Freezes or Fails to Launch; Failure to Power Up; Excessive Heating; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM WAS NOT POWERING ON, THE CUSTOMER DESCRIBED THAT IT SMELT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183318 ↗
• MalfunctionJun 10, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED. IT WAS REPORTED THAT THE SCREEN WAS FLICKERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180188 ↗
• MalfunctionMay 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THE IMAGE DID NOT DOWNLOAD. PATIENT PRESENCE UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059518 ↗
• MalfunctionDec 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE ACCURACY "AFTER RECORDING." DURING NAVIGATION, THE SURGEON CONFIRMED AN INACCURACY OF APPROXIMATELY 8MM PREOPERATIVELY DURING A CRANIAL BIOPSY PROCEDURE. THE USE OF NAVIGATION WAS ABORTED, AND THE PROCEDURE WAS UNABLE TO BE COMPLETED ON THE DATE OF THE REPORT DUE TO THE INACCURACY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856454 ↗
• InjuryNov 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AKGUN, M.Y., MANICI, M., ATES, O., GOKDEMIR, M., GUNERBUYUK, C., TEPEBASILI, M.A., BARAN, O., AKGUL, T., OKTENOGLU, T., SASANI, M., OZER, A.F. UNLOCKING PRECISION IN SPINAL SURGERY: EVALUATING THE IMPACT OF NEURONAVIGATION SYSTEMS. DIAGNOSTICS. 2024. 14 (1712). HTTPS://DOI.ORG/10.3390/DIAGNOSTICS14161712 ABSTRACT: OBJECTIVE: IN SPINE SURGERY, ENSURING THE SAFETY OF VITAL STRUCTURES IS CRUCIAL, AND VARIOUS INSTRUMENTS CONTRIBUTE TO THE SURGEON¿S CONFIDENCE. THIS STUDY AIMS TO PRESENT OUTCOMES FROM SPINAL CASES OPERATED ON USING THE FREEHAND TECHNIQUE AND NEURONAVIGATION WITH AN O-ARM IN OUR CLINIC. ADDITIONALLY, WE INVESTIGATE THE IMPACT OF SURGICAL EXPERIENCE ON OUTCOMES BY COMPARING EARLY AND LATE CASES OPERATED ON WITH NEURONAVIGATION. METHOD: WE CONDUCTED A RETROSPECTIVE ANALYSIS OF SPINAL PATIENTS OPERATED ON WITH THE FREEHAND TECHNIQUE AND NEURONAVIGATION IN OUR CLINIC BETWEEN 2019 AND 2020, WITH A MINIMUM FOLLOW-UP OF 2 YEARS. CASES OPERATED ON WITH NEURONAVIGATION USING THE O-ARM WERE CATEGORIZED INTO EARLY AND LATE GROUPS. RESULTS: THIS STUDY INCLUDED 193 PATIENTS, WITH 110 UNDERGOING THE FREEHAND TECHNIQUE AND 83 OPERATED ON UTILIZING O-ARM NAVIGATION. THE FIRST 40 CASES W

  Patient problems: Post Operative Wound Infection

  MAUDE report 20694454 ↗
• MalfunctionOct 18, 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 WHILE PERFORMING A PLANNED MAINTENANCE (PM), THE SYSTEM WAS UNPLUGGED FROM WALL POWER AND WOULD NOT BOOT UP. THERE WAS NO PATIENT INVOLVEMENT. TROUBLESHOOTING WAS PERFORMED, THE FIELD REPRESENTATIVE (REP) FLIPPED BATTERY DISCONNECT SWITCH AND ATTEMPTED TO BOOT SYSTEM WITH NO EFFECT. NO FANS COULD BE HEARD WHEN SYSTEM WAS CONNECTED TO WALL POWER OR WHEN POWER BUTTON WAS PRESSED. NO BREAKERS WERE FLIPPED ON THE UNINTERRUPTABLE POWER SUPPLY (UPS.) THE REP RECEDED EXTERNAL/INTERNAL POWER CABLE CONNECTION WITH NO EFFECT. THE REP INSPECTED INCOMING POWER CHAIN INCLUDING FUSES, FOUND NO ISSUES. THE PROBABLE CAUSE WAS NOTED TO BE AN ISSUE WITH THE BATTERY AND UPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20480702 ↗
• MalfunctionFeb 25, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THERE WAS NO CONNECTION WITH THE ELECTROMAGNETIC NAVIGATION INTERFACE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9749933 ↗
• MalfunctionNov 5, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN SETTING UP FOR THE CASE, THE AXIEM BOX WAS NOT WORKING CORRECTLY. IN THE EMITTER DETAILS AND EVERYTHING WAS RED INDICATING NO COMMUNICATION. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8039133 ↗