StealthStation® S7® 9733886Recalls & reported problems
Medtronic Navigation, Inc. · FRAME 9733886 SMALL ACTIVE HC · Class 2
All models of Stealthstation S7 (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994480668), received between Nov 24, 2024 and Nov 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Sensing Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2024Device Sensing Problem; Device Sensing Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE CALIBRATING THE NAVIGATION SYSTEM AND IMAGING SYSTEM, THE ACTIVE FRAME STOPPED TRACKING ON THE NAVIGATION SYSTEM. JUST RECEIVED THE ACTIVE FRAME ON FRIDAY, (B)(6) 2023. PLUGGED INTO DIFFERENT PORTS AND WAS STILL UNABLE TO SEE IT. CHECKED INSTRUMENT TAB AS WELL AND IT WAS NOT TRACKING. THE CONCAVE POINTER WAS TRACKING THOUGH. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE MANUFACTURER REPRESENTATIVE REMOVED THE SIDE PANEL TO MAKE SURE THE BOX FOR THE CONNECTION LOOKED OKAY. THE MORE THE MANUFACTURER REPRESENTATIVE TROUBLESHOOTED, THEY NOTICED THAT THE ACTIVE FRAME WAS GOING IN AND OUT OF CONNECTION. WHEN THE CORD WAS MOVED INTO A CERTAIN WAY, IT WOULD WORK. THE MANUFACTURER REPRESENTATIVE TAPED THE CORD DOWN TO KEEP A SOLID CONNECTION WHICH WORKED. THE MANUFACTURER REPRESENTATIVE ALSO USED IT FOR ANOTHER CALIBRATION (B)(6)2023 AND IT SEEMED TO WORK WITHOUT ANY LOSS OF CONNECTION. THE MOST LIKELY / SUSPECTED CAUSE OF THE EVENT WAS THE CORD MAY BE WEARING DOWN SINCE IT WAS GOING IN AND OUT OF CONNECTION, AND THE MANUFACTURER REPRESENTAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20768878 ↗
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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