LoFric® Origo™ 44312 (REF 4431240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07333387043319), received between Jan 12, 2024 and Jun 26, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Manufacturing, Packaging or Shipping Problem; Patient Device Interaction Problem; Manufacturing, Packaging or Shipping Problem; Patient Device Interaction Problem

  ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. MALE PATIENT REPORTED THAT 5-6 OF HIS CATHETERS RECENTLY FELT LIKE THEY HAD SHARP RIDGES ON THEM. AFTER USING ONE OF THE CATHETERS, HE DISINFECTED IT AND EXAMINED IT BY HAND. HE DESCRIBES THAT HE COULD FEEL LIKE A "CHISEL MARK". ON TWO OCCASIONS HE EXPERIENCED MINOR BLEEDING AFTER USING CATHETERS THAT HE PERCEIVED AS SHARP. HE DID NOT SEEK ANY MEDICAL ATTENTION AND HAS RECOVERED WELL.

  Patient problems: Genital Bleeding

  MAUDE report 22335863 ↗
• MalfunctionFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT USER (PATIENT) REPORTED THAT 3 URINARY CATHETERS FROM THE SAME BOX HAD A CUT AT THE LOWER PART OF THE SINGLE STERILE PACKAGE. PATIENT CLAIMED, WHEN HE ACTIVATED THE WATER SACHET FOR WETTING OF THE HYDROPHILIC SURFACE, THE FLUID FLUSHED OUT ON THE FLOOR. IT IS LIKE A SMALL PART OF THE PACKAGE HAS BEEN CUT OFF. THE PATIENT USED TWO OF THE CATHETERS WITH THE SAME FAULT BUT DIDN'T EXPERIENCE ANY PROBLEMS DURING CATHETERIZATION OR AFTERWARDS. HE DID NOT GET A UTI OR ANY OTHER MEDICAL ISSUES DUE TO THIS AND REPORTS THAT HE IS DOING FINE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18737480 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WITH BENIGN PROSTATIC HYPERPLASIA RECEIVED 2 BOXES OF INTERMITTENT URINARY CATHETER, BRAND NAME: LOFRIC ORIGO 40CM CH12. THE PATIENT CLAIMED THAT SOME CATHETERS WERE SOMEHOW GLUED TO ITS PACKAGE AND WHEN THEY WERE ACTIVATED WITH THE WETTING FLUID (SALT SOLUTION), THE COATING BECAME VERY STICKY AND NOT EVENLY DISTRIBUTED ACROSS THE CATHETER TUBE. THE PATIENT REPORTED A URINARY TRACT INFECTION (UTI), WHICH HE BELIEVES COULD POSSIBLY BE DUE TO THIS CATHETER. ACCORDING TO THE COMPLAINT THE PATIENT NEEDED TWO TREATMENTS, ONE WITH A GENERAL ANTIBIOTIC AND ONE WITH AN SPECIFIC ANTIBIOTIC (15 DAYS IN TOTAL). THE PATIENT CURRENTLY FEELS VERY WELL AND HAS RECOVERED AFTER THE TWO ANTIBIOTIC TREATMENTS. NO OTHER HARMS OR INJURIES HAS BEEN REPORTED BY THE PATIENT FOR THIS COMPLAINT.

  Patient problems: Urinary Tract Infection

  MAUDE report 18500730 ↗