Stealth AXiS 9736481Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000984441), received between Aug 26, 2026 and Sep 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Failure; Activation, Positioning or Separation Problem

  Medtronic received information regarding a navigation device being used intra-operatively during a sacroiliac and thoracolumbar procedure. It was reported that the trajectories could not be reached. All were marked as red. The site attempted to reposition to R-L5 and the trajectory guide ran into the patient reference frame clamped on L4. Surgeon grabbed the arm to stop it using the force sensor. Performed anatomy checks with probe to confirm accuracy. Accuracy was confirmed and the procedure proceeded without re-registration. Used the probe to manually send the arm to trajectories, as the original trajectories were still marked as unreachable. No known impact to patient outcome. There was a less than one hour surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946488 ↗
• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888774 ↗
• MalfunctionSep 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888757 ↗
• MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788473 ↗
• MalfunctionSep 1, 2026Use of Device Problem; Application Program Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546152 ↗
• MalfunctionAug 26, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459871 ↗