Lokomat Pro 6.3 FD ADRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640174660414), received between Aug 6, 2026 and Aug 6, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Improper or Incorrect Procedure or Method

  During the sixth session with the Lokomat, the patient expressed a desire to increase her walking duration to 40 minutes. At approximately 35 minutes into the session, she began to exhibit fatigable clonus in the right calf muscle complex. Despite this, she remained able to achieve adequate foot clearance with the assistance of foot lifters. The patient reported that her foot felt "weird"; at that point, clonus was explained to her, and reassurance was provided that this can occur in the context of fatigue. As the patient was close to achieving her session goal and she was encouraged to continue walking safely with support, the decision was made to continue for a further 2-3 minutes before resting. At approximately 38 minutes, the Lokomat stumble detection / cut-off feature activated, leaving the patient's right foot trapped behind her, positioned in plantar flexion and inversion within the foot lifter.

  Patient problems: Bone Fracture(s)

  MAUDE report 50156509 ↗