LoFric® 40408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387038360), received between Sep 2, 2024 and Mar 5, 2026 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 5, 2026Sharp Edges

  PRODUCT PROBLEM OCCURRED OUTSIDE US, IN THE REPUBLIC OF KOREA. USER OPENED THE PRIMARY PACKAGING OF THE CATHETER AND DISCOVERED THE TIP WAS POINTED. ONLY ONE PRODUCT WAS DISCOVERED WITH THIS PROBLEM AND THE USER DID NOT USE THE PRODUCT. THE USER CONTACTED THE LOCAL DISTRIBUTOR AND INFORMED ABOUT THIS PRODUCT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516492 ↗
• MalfunctionSep 2, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS COMPLAINT OCCURED OUTSIDE US, IN SOUTH KOREA AND HAS BEEN REPORTED TO THE KOREAN MFDS (MINISTRY OF FOOD AND DRUG SAFETY). THE COMPLAINT DESCRIBES A HAIR FOUND IN THE WELDING STRIP ON THE PRIMARY PACKAGE OF A UROLOGICAL CATHETER, BETWEEN THE FRONTSIDE AND BACKSIDE OF THE FOIL. THE FRONT SIDE AND BACKSIDE OF THE FOIL ARE WELDED TOGETHER TO CREATE THE SINGLE PACKAGE STERILE BARRIER, PROTECTING THE CATHETER UNTIL USE. THE HAIR WAS DISCOVERED PRIOR TO USE AND WAS NOT IN CONTACT WITH CATHETER SURFACE WHICH NORMALLY HAS DIRECT BODY CONTACT. NO CLINICAL IMPACT NOR HARM IS REPORTED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116476 ↗