Active Heel Traction Boot 72202682Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885554024807), received between Feb 8, 2018 and Aug 12, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT WHILE PREPARING FOR A HIP ARTHROSCOPY, THE SCREW IN THE BLACK PLASTIC OF THE ACTIVE HEEL TRACTION BOOT SNAPPED, CAUSING THE PATIENT'S FOOT TO BE UNABLE TO BE SECURED, THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA AND THE CASE POSTPONED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782987 ↗
• MalfunctionJul 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING A RIGHT HIP ARTHROSCOPY AND ACETABULAR LABRAL REPAIR, THE STRAPS OF THE ACTIVE HEEL TRACTION BOOT DID NOT WORK TO ADJUST, WITH GREATER DIFFICULTY THE STRAP THAT GOES ON THE ANKLE PART. WHEN DOING TRACTION, THE ANKLE STRAP CAME LOOSE, WHICH MADE THE SURGERY DIFFICULT AND THE DOCTOR WAS UNCOMFORTABLE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666271 ↗
• MalfunctionMar 30, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SET UP OF HIP ARTHROSCOPY, THE ACTIVE HEEL TRACTION BOOT WOULD NOT STAY TIGHT ON CLAMPS. THE STRAPS KEPT SLIPPING THROUGH THE CLAMPS; THEREFORE, LOST ANY TRACTION APPLIED TO THE HIP. THE STRAPS APPEARED WORN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT 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 11590348 ↗
• MalfunctionSep 17, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT BEFORE AN ARTHROSCOPY, THE FOAM SOLE OF THE ACTIVE HEEL TRACTION BOOT HAS COME AWAY FROM THE BACK OF THE BOAT CAUSING ISSUES WHEN SECURING THE PATIENTS FOOT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME 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 Patient Involvement

  MAUDE report 10546078 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER FINISHING A HIP ARTHROSCOPY, WHEN THE DOCTOR UNTIED THE PATIENT FROM THE "TRACTION TABLE BOOT", A MILD ABRASION WAS FOUND ON THE SKIN OF THE PATIENT'S LEFT FOOT; SPECIFICALLY IN THE HAGLUND DEFORMITY IN THE DORSAL ANKLE AREA DUE TO HER CALLUS/BONY DEFORMITY. THE AREA WAS CLEANED THOROUGHLY AND STERILE PETROLEUM JELLY GAUZES WERE PLACED FOR PROTECTION/TREATMENT OF SKIN LESION. IT IS UNKNOWN IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE AND NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Abrasion

  MAUDE report 10477628 ↗
• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ACTIVE HEEL TRACTION BOOT WAS NOT HOLDING TIGHT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10452346 ↗
• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ACTIVE HEEL TRACTION BOOT WAS NOT HOLDING TIGHT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10451663 ↗
• MalfunctionAug 19, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING ARTHROSCOPY, WHILE TIGHTENING THE ORANGE STRAPS ON THE ACTIVE HEEL TRACTION BOOT THE BOLT/WASHER THAT HOLDS THESE STRAPS IN PLACE SNAPPED AND BROKE AWAY FROM THE BOOT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW WAS THE PROCEDURE COMPLETED. 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 Known Impact Or Consequence To Patient

  MAUDE report 10425776 ↗
• MalfunctionAug 19, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHILE TIGHTENING THE ORANGE STRAPS ON THE ACTIVE HEEL TRACTION BOOT, THE BOLT/WASHER THAT HOLDS THESE STRAPS IN PLACE SNAPPED AND BROKE AWAY FROM THE BOOT. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING A S+N BACKUP 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 Known Impact Or Consequence To Patient

  MAUDE report 10425684 ↗
• MalfunctionFeb 8, 2018Break

  IT WAS REPORTED THAT WHILE THE PATIENT WAS UNDER TRACTION AND THE DOCTOR WAS OPERATING THE CENTER STRAP OF THE ACTIVE HEEL TRACTION BOOT BUSTED AND THE CLASP BROKE. THE DOCTOR LOST IMMEDIATE TRACTION. THERE WERE NO INSTRUMENTS IN THE JOINT AT THE TIME. PROCEDURE WAS DELAYED FOR MORE THAN TWO HOURS WHILE GETTING A BACKUP DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7252900 ↗