LoFric® Elle™ 4181225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07333387024202), received between Apr 29, 2025 and Sep 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionSep 3, 2025Break; Break

  ADVERSE EVENT OCCURRED OUTSIDE US, IN UK. A 58-YEAR OLD FEMALE PATIENT WITH A HISTORY OF NEUROGENIC BLADDER AND INTERSTITIAL CYSTITIS REPORTED A MALFUNCTION FOR A STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER LOFRIC ELLE. THE CATHETER WAS INSERTED AS NORMAL BUT UPON WITHDRAWAL THE CATHETER BROKE. THE CATHETER TUBE CAME OFF THE HANDLE AND WAS LEFT INSIDE THE PATIENT'S URETHRA. PATIENT MANAGE TO RETRIEVE THE CATHETER TUBE. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. PATIENT HASN'T HAD ANY PROBLEMS WITH ANY OTHER CATHETERS IN THE SAME LOT BUT DECIDED TO RETURN THE REST OF THE PRODUCTS IN THIS LOT IN CASE MORE ARE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951091 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN INCIDENT OCCURRED OUTSIDE THE UNITED STATES. A 58-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF NEUROGENIC BLADDER AND INTERSTITIAL CYSTITIS REPORTED EXPERIENCING TRAUMA AND BLEEDING FOLLOWING THE USE OF A LOFRIC ELLE INTERMITTENT URINARY CATHETER. THE CATHETER WAS INSERTED WITHOUT DIFFICULTY; HOWEVER, UPON WITHDRAWAL, IT WAS VISIBLY COVERED IN BLOOD. THE PATIENT EXPERIENCED SIGNIFICANT PAIN AND BLEEDING FOR APPROXIMATELY 4 TO 5 HOURS, ESTIMATING THE VOLUME AT ½ TO 1 TEASPOON PER EPISODE. THE PATIENT DID NOT SEEK EMERGENCY MEDICAL CARE BUT CONTACTED HER GENERAL PRACTITIONER (GP), WHO ADVISED MONITORING THE CONDITION. INITIALLY, THE PATIENT BELIEVED THE CATHETER ITSELF HAD CAUSED A URETHRAL INJURY. HOWEVER, AFTER REFLECTING ON THE SITUATION, SHE RECONSIDERED THE CAUSE OF THE TRAUMA. SHE NOW BELIEVES IT MAY NOT HAVE BEEN THE CATHETER ITSELF, BUT POSSIBLY A PRE-EXISTING BLISTER, SORE, OR SMALL LESION IN OR NEAR THE URETHRAL AREA THAT WAS AGGRAVATED DURING CATHETERIZATION. SHE SUGGESTED THAT WHEN SHE INSERTED OR REMOVED THE CATHETER, IT MAY HAVE RUBBED AGAINST OR IRRITATED THIS ALREADY SENSITIVE OR DAMAGED AREA, LEADING TO THE BLEEDING AND PAIN SHE EXPERIENCED. THE PATIENT DISCAR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Localized Skin Lesion

  MAUDE report 22564518 ↗
• MalfunctionApr 29, 2025Break; Break

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. ON (B)(6) 2025, A FEMAL PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED A MALFUNCTION FOR THE STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER LOFRIC ELLE (10CM, CH12). THE PATIENT REPORTED THAT THE CATHETER BROKE, THE FUNNEL WHICH IS GLUED TO THE CATHETER HAD COME LOSE DURING USE OF THE DEVICE. THE PATIENT WAS CAUSED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924320 ↗