NA 9734048RRecalls & reported problems
Medtronic Navigation, Inc. · PLNG STATION 9734048R STEALTHSTATION S7 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169777316), received between May 14, 2019 and Apr 1, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission 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 18, 2026.
Most reported problems
Device problems
- Communication or Transmission Problem1
- Computer Software Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2021Communication or Transmission Problem; Communication or Transmission Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MEMORY WAS FULL SO THERE WAS NO COMMUNICATION WITH PACS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11602857 ↗MalfunctionMay 14, 2019Computer Software Problem; Computer Software Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT DURING A STEREOTACTIC DBS DEMO, AFTER LOADING EXAMS AND WHILE REVIEWING THEM IN THE SELECT PATIENT AND PLANNING TASKS SOME OF THE SLICES FOR DIFFERENT EXAMS APPEARED BLANK OR DISTORTED. THIS OCCURRED FOR MULTIPLE EXAMS FOR DIFFERENT PATIENT DATASETS. AFTER REBOOTING THE SYSTEM, THE EXAMS APPEARED CORRECTLY, AND THE ISSUE WAS NOT ABLE TO BE REPRODUCED." NO PATIENT PRESENT.
Patient problems: No Patient Involvement
MAUDE report 8610367 ↗
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- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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