StealthStation® Cranial 9735585 (UDI 00643169625532)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169625532), 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).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K153660); 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.

Recalls naming this device

1. Sep 26, 2018Class ITerminated

   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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153660. One submission often covers many models, so check the product and lot details in each record.

• Z-1666-2023 · Apr 11, 2023 · Open, Classified
  StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
• Z-1995-2020 · Aug 9, 2019 · Terminated
  Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen