Traction boot, adult 10018800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046768000056), received between Feb 6, 2024 and Aug 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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. 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.

• MalfunctionAug 6, 2026Unintended Movement; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152976 ↗
• MalfunctionFeb 6, 2024Positioning Failure; Material Split, Cut or Torn; Positioning Failure; Material Split, Cut or Torn

  ON (B)(6) 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 10018800 - TRACTION BOOTS, PAIR. AS IT WAS STATED, THE BELT WAS TORN WHILE THE PATIENT'S FOOT WAS BEING FIXED ON THE RIGHT TRACTION BOOT DURING A HIP ARTHROSCOPY SURGERY. THE PATIENT HAD ALREADY BEEN ANESTHETIZED WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, THE SURGERY WAS POSTPONED TO A LATER DATE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE FIXATION BELT BREAKING DURING USE WHICH COULD POTENTIALLY LEAD TO A CHANGE IN THE POSITION OF THE PATIENT'S LEG AND RESCHEDULED SURGERY ON THE ALREADY ANESTHETIZED PATIENT, WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650906 ↗