PROFORE KIT USA ANKLE 18-25CM 66020016Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05000223411244), received between Nov 26, 2021 and Feb 21, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2022Device Difficult to Setup or Prepare; Material Integrity Problem; Device Difficult to Setup or Prepare; Material Integrity Problem

  IT WAS REPORTED THAT, UPON INSPECTION, THREE (3) PROFORE KITS APPEARED TO BE STRETCHED AND WITH HOLES. IN ADDITION, IT SEEMS TO BE DIFFICULT TO UNROLL THEM. TREATMENT WAS COMPLETED USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573328 ↗
• MalfunctionDec 29, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE 4TH LAYER OF A BOX OF PROFORE MULTI-LAYER HIGH COMPRESSION BANDAGING SYSTEM DOES NOT COME OFF OF THE ROLL VERY EASILY. IT APPEARS THAT THE LAYERS ARE STICKING TO EACH OTHER. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111173 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968085 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968071 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968049 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT, TEN (10) PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968028 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968023 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967993 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967975 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967955 ↗
• MalfunctionDec 9, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967927 ↗
• MalfunctionNov 26, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTER THAT, PROFORE KIT ANKLE 18-25CM USA CASE 8 SEEMS TO BE STICKING TO ITSELF AND LOOPING CAUSING IT TO BE VERY DIFFICULT TO IMPOSSIBLE TO GET A ACCURATE COMPRESSION. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878170 ↗