Indego Therapy 501-110-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M704501110001), received between Aug 26, 2020 and Aug 26, 2020 — classified as 2 injuries.

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.

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.

• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS USING THE DEVICE WITH NO ISSUES NOTED DURING THE THERAPY SESSION. THE DAY AFTER THE SESSION, THE PATIENT NOTICED SWELLING IN HER RIGHT FOOT AND CONSULTED WITH HER DOCTOR, WHO SENT HER FOR AN X-RAY. THE X-RAY WAS REQUESTED BY PARKER HMC BUT HAS NOT BEEN PROVIDED AND ALLEGEDLY CONFIRMED FRACTURE OF THE FIFTH METATARSAL. THE PATIENT'S DOCTOR APPLIED A CAST TO THE PATIENT'S FOOT. IT IS UNKNOWN IF THE DEVICE WAS INVOLVED IN THE INJURY. THE CLINIC INDICATED THAT HE PATIENT HAD A TENDENCY TO WALK ON THE OUTSIDE OF HER FEET. THE PATIENT HAD PREVIOUSLY COMPLETED MULTIPLE SESSIONS WITH THE DEVICE.

  Patient problems: Bone Fracture(s); Swelling

  MAUDE report 10454301 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS USING THE INDEGO THERAPY DEVICE DURING A THERAPY SESSION WHEN HE FELT DISCOMFORT IN HIS FOOT. THE THERAPIST STOPPED THE SESSION UPON NOTICING THAT THE PATIENT'S RIGHT FOOT WAS SWOLLEN, AND CONTACTED THE PATIENT'S DOCTOR. THE DOCTOR SENT THE PATIENT FOR X-RAYS, WHICH ALLEGEDLY INDICATED THAT THE PATIENT HAD A BROKEN FIFTH METATARSAL ON THE RIGHT FOOT. NO CASTING WAS APPLIED TO THE BROKEN BONE. THE X-RAYS WERE REQUESTED BY PARKER HMC, BUT HAVE NOT BEEN PROVIDED. THE PATIENT HAD PREVIOUSLY COMPLETED SIX SESSIONS WITH THE INDEGO THERAPY. THE CLINIC INDICATED THAT THE PATIENT HAD A TENDENCY TO WALK ON THE OUTSIDE OF THEIR FOOT.

  Patient problems: Bone Fracture(s); Swelling

  MAUDE report 10454299 ↗