Active Heel Traction Boot 72203275Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010656377), received between Jan 27, 2021 and Feb 9, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING THE SET UP USING THE ACTIVE HEEL TRACTION BOOT, AS SOON AS THE DOCTOR PUT TRACTION ON THE PATIENT FOOT THE STRAP/BUCKLE OF THE CENTER STRAP ASSEMBLY CAME APART. HE ENSURED IT WAS CLIPPED IN AND STRAPPED PROPERLY BUT THE BUCKLES WERE NOT HOLDING TIGHTLY. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE 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 11305623 ↗
• 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 11273900 ↗
• 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 11273820 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE CENTER STRAP BUCKLE BROKE WHEN IT WAS BEING BUCKLING UP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 11241690 ↗