PROFORE LITE LF SYSTEM KIT Case 8 66000771Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05000223459154), received between Feb 26, 2021 and Nov 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING TREATMENT, THE LAST 1/4TH PART OF THREE (3) PROFORE ROLLS WAS SO TIGHT THAT IT COULD NOT BE UNWIND TO GET IT OFF TO APPLY TO PATIENT. TOO MUCH TENSION WAS OBSERVED. TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770789 ↗
• MalfunctionOct 11, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING TREATMENT, 2 PROFORE LITE LF SYSTEM KIT CASE 8 COBAN LAYER OF COMPRESSION SYSTEM WERE DIFFICULT TO UNROLL TOWARDS THE END AND THE REMAINDER OF THE ROLL BECAME UNUSABLE. TREATMENT HAD TO BE COMPLETED WITH A BACKUP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610586 ↗
• MalfunctionOct 11, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING TREATMENT, 2 PROFORE LITE LF SYSTEM KIT CASE 8 COBAN LAYER OF COMPRESSION SYSTEM WERE DIFFICULT TO UNROLL TOWARDS THE END AND THE REMAINDER OF THE ROLL BECAME UNUSABLE. TREATMENT HAD TO BE COMPLETED WITH A BACKUP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610549 ↗
• MalfunctionAug 6, 2021Nonstandard Device; Failure to Unfold or Unwrap; Nonstandard Device; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT PROFORE LITE LF SYSTEM KIT CASE 8 (BROWN OUTER BANDAGE) WAS TOO TIGHTLY WOUND ON THE ROLL. THIS MADE IT ALMOST IMPOSSIBLE TO APPLY THE BANDAGE SINCE IT DID NOT WANT TO LOOSEN FROM THE ROLL. TREATMENT WAS FINISHED WITH THE SAME DEVICE ALTHOUGH THE DRESSING STARTED TO GET STUCK ON ITSELF WHICH LEAD TO PATIENT DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 12288396 ↗
• MalfunctionFeb 26, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT, THE BROWN COHESIVE ROLL CANNOT BE UNWOUND AND IS SEVERELY STUCK TOGETHER. IT IS UNKNOWN WHEN DID THE EVENT OCCURRED AND IF THERE WAS A PATIENT INVOLVEMENT. NO OTHER COMPLICATIONS WHERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384798 ↗