Stealthstation® S7™ 9733857 (UDI 00643169505735)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169505735), received between Jul 2, 2018 and Sep 12, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR CAN¿T DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728994 ↗
• InjuryJul 9, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE AMOUNT OF INACCURACY WAS UNKNOWN. THE SURGEON ALLEGED THAT IT WAS CAUSED BY THE INACCURACY OF THE IMAGING SYSTEM.

  Patient problems: Tissue Damage

  MAUDE report 10251905 ↗
• MalfunctionNov 21, 2019Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO DELAY TO THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353050 ↗
• MalfunctionSep 6, 2018Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE, THE SYSTEM BECAME UNRESPONSIVE. THE ISSUE WAS RESOLVED BY REBOOTING THE SYSTEM. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852049 ↗
• MalfunctionAug 6, 2018Computer Software Problem; Electrical /Electronic Property Problem; Computer Software Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS UNRESPONSIVE DURING PLANNING AND THE ISSUE WAS RESOLVED BY REBOOTING. THE COMPUTER WAS REPLACED SEVERAL MONTHS AGO NONETHELESS THE ISSUE THAT THE SYSTEM WAS UNRESPONSIVE OCCURRED FOR SEVERAL TIMES AFTER THE REPLACEMENT. IN ADDITION, THE COPY AND OVERWRITING OF REGISTRATION POINTS DURING PLANNING OCCURRED AGAIN. AFTER CREATING REGISTRATION POINTS, DEVIATION OF LEVEL WAS NOTICED. FOLLOWING RECREATING THE REGISTRATION POINTS, OVERWRITING OCCURRED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 7752410 ↗
• MalfunctionJul 30, 2018Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND DELAYED THE SURGERY BY 20 MINUTES. IT WAS REPORTED THAT THE EM STYLET HAS RECOGNITION FAILURE. THE EM STYLET WAS REPLACED WITH A NEW ONE AND THE REPLACED ONE COULD BE RECOGNIZED NORMALLY. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732958 ↗
• MalfunctionJul 2, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A SPINAL FUSION, THE NAVIGATION SYSTEM DISPLAYED NO SIGNAL ON THE MONITOR FOLLOWING REGISTRATION. RESTARTING THE NAVIGATION SYSTEM DID NOT RESTORE FUNCTIONALITY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656990 ↗