Stealth Autoguide™ System 29631Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000293659), received between Aug 21, 2020 and Jun 26, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

1 other recall cover devices cleared under the same FDA submission (K191597); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE AUTOMATED TRAJECTORY GUIDANCE UNIT SETUP WAS CORRECT, BUT THE TARGETING UNIT WAS UNABLE TO MOVE. NO ERROR CODE OR ANY WARNING SYMBOL ON THE AUTOMATED TRAJECTORY GUIDANCE UNIT. TECHNICAL SERVICES (TS) HAD A MANUFACTURER REPRESENTATIVE (REP) MOVE THE TARGETING UNIT TO A MORE FAVORABLE POSITION IN RELATION TO THEIR PLAN, THE UNIT MOVED TO PLANNED TRAJECTORY, AND THE SITE WAS ABLE TO MOVE FORWARD WITH SURGERY. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22339039 ↗
• InjuryAug 22, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A BRAIN PROCEDURE. IT WAS REPORTED THAT THE SITE'S ROBOTIC GUIDANCE WAS DISPLAYING TWO DIFFERENT ERROR CODES. FIRST, IT BOOTED INTO ERROR 0021 (CABLING FAULT ON THE COMMUNICATION LINE TO THE ROBOTIC GUIDANCE CONTROL UNIT). ALL CORDS WERE RE-SEATED AND SYSTEM REBOOTED, BUT THEN THE TARGETING UNIT ONLY BOOTED INTO A SCREEN WITH ERROR 0072 (ROBOTIC GUIDANCE TARGETING UNIT DOES NOT START PROPERLY: CONFIGURATION ERROR OR SELF TEST ERROR). MULTIPLE REBOOTS WERE ATTEMPTED WITH NO CHANGE. DELAY INFORMATION WAS UNKNOWN. THERE WAS NO REPORTED IMPACT TO THE PATIENT. IT WAS NOTED THAT NAVIGATION WAS ABORTED, AS WELL AS THAT THE PROCEDURE WAS RESCHEDULED. THIS IS CONFLICTING INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SUSPECTED CAUSE OF THE ISSUE WAS THE TARGETING UNIT RUNNING INTO THE ARM. THE PROCEDURE WAS RESCHEDULED. THE SITE HAD ALREADY MADE THE BURR HOLE WHEN THE TARGETING UNIT WENT DOWN. THE DELAY WAS ABOUT 20MINS OR SO PRIOR TO ABORTING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266222 ↗
• MalfunctionApr 4, 2022Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A DAMAGED CONTROL UNIT CABLE. THE SYSTEM WOULD POWER OFF WHEN IT WAS ANGLED A CERTAIN WAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13998885 ↗
• MalfunctionMar 23, 2021Device Sensing Problem; Device Sensing Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE WAS RESOLVE BY REPLACING THE SSD AND THE CONTROL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552980 ↗
• InjuryAug 21, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM AND AUTOMATED TRAJECTORY GUIDANCE UNIT BEING USED FOR A THERMAL THERAPY LASER PLACEMENT. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE SURGEON USED THE AUTOMATED TRAJECTORY GUIDANCE UNIT AND THERMAL THERAPY SYSTEM DRILL GUIDE SET TO DRILL A HOLE AND THE HOLE ENDED UP LARGER THAN EXPECTED AND THE BONE ANCHORS WOULD NOT FIT THE HOLE. THEY HAD TO DRILL ANOTHER HOLE USING A SHORTER DRILL GUIDE. THE PROCEDURE WAS COMPLETED WITH A THIRTY MINUTE DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THE SURGEON SUSPECTED THAT IT OVERBORED THE HOLE DUE TO SOFT BONE, THE DRILL HAD TO BE PULSED IN AND OUT TO MAKE SURE THEY DIDN'T GO TOO DEEP, AND THE SURGEON ALLEGED THAT THE LONGER THERMAL THERAPY DRILL GUIDE WAS LESS STABLE THAN THE SHORT DRILL GUIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437081 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191597. One submission often covers many models, so check the product and lot details in each record.

• Z-0417-2022 · Nov 9, 2021 · Open, Classified
  Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.