LoFric® Hydro-Kit™ 42512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387042947), received between Dec 8, 2025 and Jan 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 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.

• MalfunctionJan 12, 2026Delivered as Unsterile Product; Unsealed Device Packaging

  PRODUCT PROBLEM OCCURRED OUTSIDE US, IN FRANCE. PATIENT REPORTS THAT THE WELD ON THE TIP OF THE STERILE PACKAGING IS OPEN AND THAT IN A CUSTOMER BOX CONTAINING 30 PRODUCTS, ALMOST ALL WERE DEFECTIVE. THE IMAGE RECEIVED WITH THE COMPLAINT SHOWS THAT THE WELD AT THE CATHETER TIP ON THE STERILE PACKAGE IS MISSING. WHEN THE INCLUDED WATER SACHET IS ACTIVATED, THE WETTING SOLUTION LEAKS OUT. 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. THE DEFECTIVE PRODUCTS WERE NOT USED AND THE PATIENT DID NOT REPORT ANY HARM OR HEALTH IMPACT. DEFECTIVE PRODUCTS WERE DISCARDED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035699 ↗
• MalfunctionDec 8, 2025Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  MALFUNCTION OCCURRED OUTSIDE US, IN FRANCE, WHERE A PATIENT REPORTS THAT THE WELD ON THE STERILE PACKAGE OPENS WHEN ACTIVATING THE URINARY CATHETER. AT LEAST 10 CATHETERS FROM THE SAME CUSTOMER BOX AND LOT WERE AFFECTED, OF WHICH THE PATIENT DISCARDED 4 AND 6 CATHETERS WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE IMAGE RECEIVED WITH THIS COMPLAINT SHOWED THAT THE WELD AT THE CATHETER TIP ON THE STERILE PACKAGE IS MISSING. WHEN THE INCLUDED WATER SACHET IS ACTIVATED, THE WETTING SOLUTION LEAKS OUT AT THE BOTTOM OF THE STERILE PACKAGE. PATIENT IS A 54-YEAR-OLD MAN WITH SEVERAL YEARS OF EXPERIENCE WITH INTERMITTENT CATHETERIZATION AND HAVE BEEN USING LOFRIC HYDRO-KIT FOR MANY YEARS. THE DEFECTIVE PRODUCTS WERE NOT USED. NO INFORMATION ABOUT PATIENTS' HEALTH CONDITION OF REASON FOR USING INTERMITTENT CATHETERS HAS BEEN COMMUNICATED. 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 23741324 ↗