Stealthstation® S7™ 9734685 (UDI 00613994806604)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994806604), received between Jul 17, 2018 and Jan 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Mechanical Problem; Connection Problem; Mechanical Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE OPTICAL PART OF THE SYSTEM WAS NOT WORKING PROPERLY. DURING THE PREPARATION OF THE OPERATING FIELD (PRE-OPERATIVE PHASE) FOR CRANIAL SURGERY BY MEANS OF OPTICAL DETECTION, THE OPTICAL SYSTEM SUDDENLY STOPPED WORKING. THE CAMERA'S POWER INDICATOR LED STARTED FLASHING AND BEEPING INTERMITTENTLY. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241223 ↗
• MalfunctionAug 19, 2022Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRAOPERATIVELY DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SITE REGISTERED MULTIPLE TIMES AND COULDN'T GET AN ACCURATE REGISTRATION. THE USE OF MEDTRONIC NAVIGATION WAS ABORTED. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257828 ↗
• MalfunctionAug 10, 2022Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD DIFFICULTY REGISTERING THE PATIENT. THEY ATTEMPTED TO TRACE FOUR TIMES WITHOUT A PASSING REGISTRATION, ALL OF WHICH HAD TRACE POINTS THAT SEEMED TO SINK INTO THE FACE. THEY ATTEMPTED TO REGISTER WITH A POINT MERGE AND ACHIEVED A PASSING REGISTRATION, BUT THE SURGEON DID NOT FEEL THAT IT WAS ACCURATE ON THE RIGHT SIDE OF THE FACE. AN ADDITIONAL TOUCHPOINT WAS ADDED ON THE RIGHT SIDE WITHOUT RESOLUTION. THE SURGEON DECIDED TO CONTINUE THE PROCEDURE WITHOUT MEDTRONIC NAVIGATION. THE EVENT CAUSED A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201835 ↗
• MalfunctionNov 11, 2020Mechanical Problem; Mechanical Problem

  HOLD FOR AB 11.12MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHILE ON SITE, IT WAS NOTICED THAT THE SURGEON MONITOR HAD A BUZZING NOISE. BASED ON PREVIOUS CASES, PROBABLE CAUSE WAS DETERMINED TO BE LIKELY DUE TO THE CART TO CART CABLE CONNECTION. NO PATIENT PRESENT. (B)(6) 2020 (REP): IT WAS REPORTED THAT THE CABLE WAS THE CAUSE OF THE BUZZING NOISE ASSOCIATED WITH THE MONITOR. IT WAS REPLACED.

  Patient problems: No Patient Involvement

  MAUDE report 10824469 ↗
• MalfunctionJan 30, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT DURING PROCEDURE, THE SCREEN WENT BLUE IN NAVIGATE MODE. THEY WERE ABLE TO USE THE VERIFY REGISTRATION SCREEN TO NAVIGATE. IT WAS NOTED THAT THE CASE COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9648682 ↗
• MalfunctionJul 17, 2018Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHEN THE SITE WAS GETTING READY TO SPIN THEY WERE NOT GETTING COMMUNICATION. LOOKING AT THE NAVIGATION, THE MOUSE WAS UNRESPONSIVE. THEY HARD BOOTED THE SYSTEM, BUT THEN IT WOULD NOT BOOT UP AND WAS DISPLAYING NO INPUT DETECTED. THEY TRIED TO BOOT A FEW TIMES TO NO AVAIL. LISTENING TO THE COMPUTER, THE FAN ON IT WAS CYCLING. MEDTRONIC NAVIGATION WAS ABORTED. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7694979 ↗