N/A 9735521Recalls & reported problems
Medtronic Navigation, Inc. · EMITTER 9735521 AXIEM 3 SIDE MOUNT · Class 2
Data updated Oct 18, 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 00763000340285), received between May 10, 2024 and May 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K162309); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Connection 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.
MalfunctionMay 10, 2024Connection Problem; Connection Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS THERE WAS CONNECTION ISSUE AND THE EMITTER WAS UNABLE TO BE CONNECTED. THE ISSUE WAS CAUSED BY A PHYSICAL MISFIT OF THE CABLE DUE TO DAMAGE. THE ISSUE DID NOT OCCUR DURING A PROCEDURE AND NO PATIENT WAS PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19291218 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.
- Z-1776-2024 · Mar 26, 2024 · Open, ClassifiedStealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
- Z-1995-2020 · Aug 9, 2019 · TerminatedMedtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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