StealthStation CranialRecalls & reported problems across all models
Medtronic Navigation, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one StealthStation Cranial model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 13 models of StealthStation Cranial by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2017 and May 5, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (2 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
StealthStation Cranial recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 11, 2023Open, Classified
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury
Z-1666-2023 · Root cause: Software design · names 5 of these models · Recall details · FDA record ↗
- Apr 11, 2023Open, Classified
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
Z-1630-2023 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Sep 26, 2018Terminated
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
Z-0552-2019 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗
Most reported StealthStation Cranial problems
Device problems
- Computer Software Problem2
- Communication or Transmission Problem1
Patient problems
- No Patient Involvement2
StealthStation Cranial models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- StealthStation® Cranial 9735585Neurological stereotaxic Instrument1 recall2 reports
- StealthStation® Cranial 9735586Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735585Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735585Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735586Neurological stereotaxic Instrument1 recall0 reports
- StealthStation® Cranial 9735587Neurological stereotaxic Instrument1 recall0 reports
Recent StealthStation Cranial adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2017Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem
A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING IN-HOUSE TESTING USING STEALTHCONNECT, NEGATIVE DECIMAL NUMBERS ENTERED INTO PLAN TASK ROUND TO NEAREST WHOLE NUMBER. CROSSHAIRS DO NOT ALWAYS UPDATE. THE SOFTWARE DOES NOT ALLOW FRACTIONAL NUMBERS IN THE TRAJECTORY, NEGATIVE DIRECTION. WHEN WANTING TO MOVE IN THE NEGATIVE DIRECTION AT .1 MILLIMETER INCREMENTS, IT ONLY GOES TO WHOLE NUMBERS. IF THE CROSSHAIRS ARE ON THE PLAN TRAJECTORY AND THE USER ENTERS A VALUE OF -0.5 < X <0 IN THE "MM TO TARGET" FIELD, THE MILLIMETER TO TARGET VALUE OF -0.5 < X <0 AND THE CROSSHAIRS UPDATE TO 0. IF THE CROSSHAIRS ARE PAST THE PLAN (E.G. MM TO TARGET IS +1) AND THE USER ENTERS A VALUE OF -0.5 < X <0 IN THE "MM TO TARGET" FIELD, THE MILLIMETER TO TARGET VALUE REMAINS AS ENTERED (DOES NOT ROUND TO ZERO) AND THE CROSSHAIRS DO NOT UPDATE. ADDITIONAL ENGINEERING INVESTIGATION: IF THE USER ENTERS A NEGATIVE DECIMAL NUMBER FOR THE DEPTH LINE EDIT VALUE AND THE VALUE FALLS BETWEEN THE ENTRY AND TARGET OF THE PLAN, THE DEPTH LINE EDIT VALUE WILL BE ROUNDED TO THE NEAREST INTEGER AND THE CROSSHAIRS SET TO THAT ROUNDED VALUE. IF THE CROSSHAIRS ARE POSITIONED PAST THE TARGET (NOT BETWEEN THE ENTRY AND TARGET)
Patient problems: No Patient Involvement
MAUDE report 6547512 ↗MalfunctionMar 2, 2017Computer Software Problem; Computer Software Problem
A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING IN-HOUSE TESTING INCORRECT FRAME SETTINGS WERE USED AFTER USING THE FULL-SCREEN FRAME SETTINGS DIALOG IN A CRANIAL SOFTWARE APPLICATION. THIS ISSUE DID NOT OCCUR IN A CLINICAL SETTING.
Patient problems: No Patient Involvement
MAUDE report 6375093 ↗
Other Medtronic Navigation, Inc. products
- O-ARM17 models · 9,235 reports · 5 recalls
- StealthStation S8 Platform14 models · 8,402 reports
- Stealthstation S711 models · 5,756 reports
- StealthStation S86 models · 2,235 reports
- Fusion ENT Image Guidance System5 models · 2,033 reports
- Visualase25 models · 625 reports · 3 recalls
- NavLock9 models · 134 reports · 1 recall
- AxiEM12 models · 62 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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