CLEAR-TRAC 72200436Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010558343), received between Dec 11, 2019 and Feb 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY TWO (2) HIP CANNULAS SEEMED TO HAVE PLASTIC DEBRIS INSIDE OF THE CANNULA. AFTER THE FIRST CANNULA WAS USED IT WAS NOTICED SOME PLASTIC DEBRIS, SO IT WAS SWITCHED OUT FOR ANOTHER CANNULA WITH THE SAME LOT. BOTH CANNULAS SEEMED TO HAVE SHREDDED PLASTIC PIECES INTO THE JOINT SPACE. ALL PIECES WERE REMOVED SAFELY. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380908 ↗
• MalfunctionDec 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE HIP SCOPE PROCEDURE, A PIECE OF THE DEVICE BROKE DOWN AND FELL INSIDE THE PATIENT. THE PIECE WAS REMOVED. NO DELAY OR PATIENT INJURIES WERE REPORTED. NO BACKUP WAS AVAILABLE. 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 9449131 ↗