LoFric® Hydro-Kit™ 42018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387042848), received between Mar 10, 2026 and Mar 10, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN FRANCE, WHERE A MALE USER REPORTED THAT THE LOFRIC HYDRO-KIT URINE COLLECTION BAG WAS PUNCTURED, RESULTING IN URINE LEAKAGE DURING USE. THE LEAKAGE OCCURRED EACH TIME THE PRODUCT WAS USED, WITH THE DEFECT LOCATED IN THE LOWER PART OF THE BAG. THE USER EXPERIENCED DISCOMFORT AND AN UNPLEASANT SITUATION AS HE BECAME WET WITH URINE DURING CATHETERIZATION. NO MEDICAL COMPLICATIONS OR ADVERSE HEALTH EFFECTS WERE REPORTED. ACCORDING TO THE INFORMATION RECEIVED, A TOTAL OF THREE (3) PRODUCTS WERE AFFECTED. ALL THREE (3) USED PRODUCTS WERE DISCARDED AND THEREFORE NOT AVAILABLE FOR INVESTIGATION. LOFRIC HYDRO-KIT IS A STERILE SINGLE USE URINARY CATHETER. EACH PRIMARY STERILE PACKAGE CONSISTS OF A CATHETER, A WATER SACHET (WETTING SOLUTION BAG) AND A URINE COLLECTION BAG. THE WETTING SOLUTION BAG IS USED TO ACTIVATE THE HYDROPHILIC CATHETER COATING BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556964 ↗