Active Heel Traction Boot 72203345Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554024845), received between Feb 3, 2021 and Feb 3, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT WAS LOOSENING AND IT WAS NOT MAINTAINING TENSION ON THE BOOT CAUSING THE PATIENT´S FOOT TO SLIDE, ULTIMATELY IMPACTING DISTRACTION. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273846 ↗
• MalfunctionFeb 3, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT WAS LOOSENING AND IT WAS NOT MAINTAINING TENSION ON THE BOOT CAUSING THE PATIENT´S FOOT TO SLIDE, ULTIMATELY IMPACTING DISTRACTION. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273771 ↗
• MalfunctionFeb 3, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT WAS LOOSENING AND IT WAS NOT MAINTAINING TENSION ON THE BOOT CAUSING THE PATIENTS FOOT TO SLIDE, ULTIMATELY IMPACTING DISTRACTION. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273686 ↗