LoFric® Hydro-Kit™ 42016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387042831), received between Feb 10, 2025 and Apr 1, 2026 — classified as 1 injury, 1 malfunction.

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.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT OCCURRED OUTSIDE US, IN GERMANY. A 65-YEAR-OLD MALE WITH A SPINAL CORD INJURY, EXPERIENCED IN INTERMITTENT CATHETERIZATION, REPORTED THAT SIX (6) LOFRIC HYDRO-KIT CATHETERS FELT SHARP-EDGED DURING USE. HE DESCRIBED THE SENSATION AS VERY UNCOMFORTABLE IN THE URETHRA; IT WAS NOT PAINFUL, BUT FELT A SLIGHT FRICTION. ON ONE (1) OCCASION, A MINOR URTETHRAL BLEEDING OCCURRED WHEN THE CATHETER WAS WITHDRAWN. THE BLEEDING WAS TRANSIENT AND DID NOT RECUR. THE PATIENT IS CURRENTLY TAKING ACIMETHIN AND DRIDASE. HE HAS USED ADDITIONAL LOFRIC HYDRO-KIT CATHETER AFTER THE INCIDENT WITHOUT EXPERIENCING SIMILAR ISSUES. LOFRIC HYDRO-KIT IS A STERILE 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: Discomfort; Pain

  MAUDE report 24755979 ↗
• MalfunctionFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT HAS BEEN USING, SEVERAL STERILE, SINGLE-USE INTERMITTENT URINARY CATHETERS LOFRIC HYDRO-KIT NELATON (40CM, CH16). ON (B)(6)2025, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT THE END OF THE PRIMARY PACKAGE WAS NOT SEALED COMPLETELY FOR SOME OF THE PRODUCTS HE HAD USED. THE PATIENT ALSO REPORTED THAT HE HAD A URINARY TRACT INFECTION. HE WAS TREATED WITH ORAL ANTIBIOTICS AND RECOVERED NORMALLY AFTER THE 10 DAYS OF TREATMENT AND IS NOW DOING WELL. THIS OCCURRED IN (B)(6) 2024 BUT THE PATIENT DID NOT REPORT IT UNTIL (B)(6) 2025.

  Patient problems: Urinary Tract Infection

  MAUDE report 21342921 ↗