LoFric® Hydro-Kit™ 42014Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07333387042824), received between Jan 30, 2025 and Feb 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN FRANCE, WHERE A PATIENT REPORTED HAVING FOUND DEFECTIVE MICRO-PERFORATED CATHETERS THAT LEAKED DURING USE. THIS OBSERVATION INDICATES A POTENTIAL COMPROMISE OF THE PRODUCT'S STERILE BARRIER. A TOTAL OF 12 PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THE TIME OF THE EVENT, THE PATIENT ALREADY HAD A DIAGNOSED URINARY TRACT INFECTION (UTI) AND RECEIVED INTRAMUSCULAR ANTIBIOTIC TREATMENT. THE PATIENT ALSO HAS UNDERLYING MEDICAL CONDITIONS, INCLUDING URINARY CALCULI AND FOURNIER'S GANGRENE. A SURGICAL INTERVENTION INVOLVING THE URETER AND THE RIGHT KIDNEY IS SCHEDULES FOR 17 FEBRUARY ALREADY BEFORE THIS INCIDENT. ACCORDING TO THE PATIENT, THE UTI IS NOT CONSIDERED RELATED TO THE USE OF THE LOFRIC HYDRO-KIT CATHETER BUT IS ATTRIBUTED TO THE PRESENCE OF URINARY STONES. NO HARM OR MEDICAL COMPLICATIONS ARE REPORTED RELATED TO THIS INCIDENT. LOFRIC HYDRO-KIT IS A STERILE SINGLE USE URINARY CATHETER. EACH PRIMARY 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: Urinary Tract Infection

  MAUDE report 24386865 ↗
• MalfunctionAug 6, 2025Break; Leak/Splash; Delivered as Unsterile Product; Break; Leak/Splash; Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN GERMANY. A MALE PATIENT HAS BEEN USING LOFRIC HYDRO-KIT NELATON (40CM, CH14) FOR AROUND 30 YEARS. LOFRIC HYDRO-KIT IS A STERILE, SINGLE USE, HYDROPHILIC CATHETER WITH SALT SOLUTION FOR ACTIVATION, INTENDED FOR INTERMITTENT URINARY CATHETERIZATION. IT HAS AN INTEGRATED URINE COLLECTION BAG (PRIMARY PACKAGE) AND IS READY TO USE ANYWHERE. THE WETTING SOLUTION IS USED TO ACTIVATE THE HYDROPHILIC CATHETER COATING BEFORE USE. ON (B)(6), 2025, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT THERE WAS A HOLE IN THE WELD SEAM IN THE URINE COLLECTION BAG. THE DEFECT IN THE URINE COLLECTION BAG WAS DISCOVERED DURING USE AND THE URINE LEAKED OUT INSTEAD OF REMAINING IN THE URINE COLLECTION BAG. THE PATIENT CATHETERIZED AT NIGHT IN BED SO UNFORTUNATELY THE URINE LEAKED ON TO THE BED. THE PATIENT MENTIONED THAT THIS HAD HAPPENED BEFORE, ABOUT 7-8 YEARS AGO. THERE IS NO INFORMATION ABOUT THE LOT NUMBER FOR THIS OCCASION. THE PATIENT DID NOT REPORT ANY HEALTH IMPACT AND WILL CONTINUE TO USE LOFRIC HYDRO-KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727037 ↗
• MalfunctionJun 11, 2025Break; Delivered as Unsterile Product; Break; Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN FRANCE, WHERE A MALE PATIENT EXPERIENCED PROBLEMS WITH THE DEVICE LOFRIC HYDRO-KIT NELATON 40CM CH14 (MODEL NO. 42014) FOR 2 MONTHS. LOFRIC HYDRO-KIT IS A STERILE SINGLE USE, HYDROPHILIC CATHETER WITH SALT SOLUTION FOR ACTIVATION. IT HAS AN INTEGRATED URINE COLLECTION BAG AND IS READY TO USE ANYWHERE. THE WETTING SOLUTION IS USED TO ACTIVATE THE HYDROPHILIC CATHETER COATING BEFORE USE. ON THREE (3) OCCASIONS, THE WELD AT THE TOP OF THE PRIMARY PACKAGING (URINE COLLECTION BAG) HAS BEEN OPENED, AND ON ANOTHER OCCASION A HOLE WAS DISCOVERED IN THE URINE COLLECTION BAG. THE HOLE IN URINE COLLECTION BAG WAS DISCOVERED WHEN PATIENT WAS USING IT, AND THE URINE LEAKED ONTO THE PATIENT INSTEAD OF REMAINING IN THE URINE COLLECTING BAG. THERE WERE NO MEDICAL COMPLICATIONS OR HARM TO THE PATIENT. THE REMAINING PRODUCTS FROM THE SAME LOT WERE DISCARDED AND THERE IS NO INFORMATION WHETHER MORE PRODUCTS HAD THE SAME DEFECT. THE PATIENT REQUESTED NEW PRODUCTS FROM A DIFFERENT LOT AND HAS NOT RETURNED WITH FURTHER COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183976 ↗
• MalfunctionJan 30, 2025Break; Delivered as Unsterile Product; Break; Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN FRANCE. FEMALE PATIENT, HAS BEEN USING LOFRIC HYDRO-KIT SINCE 2009. PATIENT WITH BLADDER EXTROPHY, SHE MUST SELF-CATHETERIZE VIA AN ABDOMINAL ROUTE THEREFORE SHE USES HYDRO-KIT 40CM CATHETER. PATIENT USED THE PRODUCT LIKE SHE USUALLY DOES, THEN URINE LEAKED OUT OF THE PACKAGING. SHE STOPPED THE CATHETERIZATION AND COULD USE ANOTHER PRODUCT FROM HER STOCK WITHOUT PROBLEM. WHEN INSPECTING THE CATHETERS AFTERWARDS, PATIENT NOTICED 5 MORE PRODUCTS HAD THE SAME PROBLEM, THE PRIMARY PACKAGE WELD WAS BROKEN AND THE STERILE BARRIER WAS COMPROMISED. PATIENT DISCARDED THESE 6 PRODUCTS WITH BROKEN PRIMARY PACKAGE WELD. THE PATIENT IS DOING FINE AND HAS NOT REPORTED ANY MEDICAL PROBLEMS OR HEALTH ISSUES RELATED TO THIS MALFUNCTION.. SHE CONTINUES TO CATHETERIZE USING HYDRO-KIT PRODUCTS AT HER DISPOSAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273855 ↗