LoFric® Origo™ 44414 (REF 4441440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07333387043432), received between Feb 7, 2025 and Feb 9, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• InjuryFeb 9, 2026Product Quality Problem; Patient Device Interaction Problem

  MALE PATIENT, THAT HAS BEEN USING CATHETERS FOR A LONG TIME. RECENTLY SWITCHED FROM STRAIGHT TIP TO COUDE TIP. RECENTLY HE HAD TWO EPISODES OF BLEEDING, THE TWO EPISODES HAPPENED WITHIN TWO WEEKS TIME. THE FIRST BLEEDING LASTED A DAY AND SELF RESOLVED. THE SECOND TIME, THE PATIENT EXPERIENCED BLEEDING DURING EACH TIME HE CATHETERIZED DURING FOUR DAYS STRAIGHT, ONLY DURING CATHETERIZATION, NOT BEFORE OR AFTER. ON THE FOURTH DAY, WHICH WAS JANUARY 25TH, THE PATIENT WENT TO URGENT CARE. THE BLEEDING HAD THEN RESOLVED AND NO BLEEDING HAS OCCURED SINCE. WHEN HE WENT TO URGENT CARE, HE ALSO EXPERIENCED FEVER AND IRREGULAR HEART RATE. HE WAS DIAGNOSED WITH UTI AND TREATED WITH IV ANTIBIOTICS. ON JANUARY 30TH THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. HE SAYS THAT HIS BLOOD PRESSURE IS OKEY NOW AND THAT HE IS FEELING OKEY BUT NOT GREAT. PATIENT WANTS TO SWITCH TO ANOTHER CATHETER BRAND. THE PATIENT DESCRIBED THE CATHETER TIP AS TOO SHARP AND THAT IT SCRATCHES THE URETHRA. HE SAYS THIS WAS A GENERAL COMPLAINT ABOUT THE COUDE TIP AND NOT SPECIFIC FOR ANY BATCH. ALSO, HE MENTIONED THAT THE COUDE INDICATOR RIDGE IS OFFSET AND THAT IT IS HARD TO REMEMBER TO CHECK THE SPECIFIC ORIENTATION. TH

  Patient problems: Genital Bleeding; Urinary Tract Infection

  MAUDE report 24290016 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WAS SENT A URINARY CATHETER OF THE WRONG SIZE (SMALLER THAN REQUIRED WITH A CURVED TIP) BY MISTAKE. PATIENT DISCOVERED THE MISTAKE AND REQUESTED AN EXPEDITE OF THE CORRECT CATHETER. THE USE OF WRONG CATHETER LED TO A MINOR BLEEDING AND PATIENT VISITED THE ER TO HAVE THIS CHECKED OUT. EVERYTHING WAS FINE AND PATIENT HAS RECOVERED. THE ERROR OCCURRED AT THE DISTRIBUTION LEVEL OF THE LOCAL WHOLESALER, WHERE THEY MIS-PICKED THE WRONG CATHETER TYPE AND SHIPPED IT TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21917255 ↗
• MalfunctionFeb 7, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  PRODUCT PROBLEM OCCURRED OUTSIDE US, IN THE NETHERLANDS. A MALE USER OF LOFRIC ORIGO TIEMANN 40CM CH14 (STERILE SINGLE-USE INTERMITTENT URINARY CATHETER) DISCOVERED PRIOR TO USE THAT THE PRIMARY PACKAGE OF THE CATHETER WAS DAMAGED. THE PRIMARY PACKAGE (STERILE BARRIER) HAD A MISSING WELD AT THE LOWER END OF THE PACKAGING. THE PRODUCT WERE NOT USED AND NO HARM OR MEDICAL COMPLICATION WERE REPORTED. SEVERAL ATTEMPTS TO CONTACT USER HAVE BEEN MADE TO GATHER FURTHER INFORMATION ABOUT THE MALFUNCTION OF THIS DEVICE BUT WITH NO RESULT. THE AFFECTED CATHETERS WAS RETURNED TO MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331894 ↗