LoFric® Origo™ 44314 (REF 4431440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07333387043333), received between Jun 28, 2024 and Nov 11, 2025 — classified as 3 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Break; Material Separation; Break; Material Separation

  AN ADVERSE EVENT OCCURRED IN THE US WHERE A YOUNG 18-YEAR-OLD WOMAN REPORTED THAT WHILE SHE WAS SELF-CATHETERIZING WITH A LOFRIC ORIGO INTERMITTENT CATHETER, IT BROKE INSIDE HER BODY. THE USER NOTICED WHEN SHE PULLED OUT THE CATHETER THAT SOMETHING WAS WRONG WITH IT BECAUSE THE CATHETER TIP WAS MISSING, THE CATHETER WAS BROKEN. SHE INITIALLY THOUGHT THAT THE CATHETER TIP MIGHT HAVE FALLEN TO THE FLOOR, BUT IT HAD NOT. THE USER VISITED HER UROLOGIST THE SAME DAY (APPROXIMATELY 2 HOURS LATER) AND HAD A CYSTOSCOPY PERFORMED WHICH REVEALED THE CATHETER TIP IN THE USER'S BLADDER. IT WAS REMOVED IN THE UROLOGIST'S OFFICE (WITHOUT SURGERY) AND THE USER WAS ABLE TO GO HOME WITHOUT ANY ANTIBIOTIC PRESCRIPTIONS. THE USER EXPERIENCED SOME TENDERNESS AND PAIN THE FOLLOWING DAY. ACCORDING TO THE USER'S GRANDMOTHER, THE CATHETER DID NOT LOOK DIFFERENT, AND THE CATHETER PACKAGING LOOKED UNOPENED. THE USER PERFORMED THE CATHETERIZATION AS INSTRUCTED, SQUEEZING THE WATER BAG (SACHET) BEFORE USE TO ACTIVATE THE CATHETER COATING. PER HER GRANDMOTHER SHE DID NOT USE ANY SHARP TOOLS (SCISSORS ETC) ON THE CATHETER OR PACKAGING. THE USER IS NEW TO CIC (CLEAN INTERMITTENT CATHETERIZATION). SHE PERFORMED C

  Patient problems: Foreign Body In Patient

  MAUDE report 23521041 ↗
• MalfunctionSep 11, 2025Break; Leak/Splash; Delivered as Unsterile Product; Break; Leak/Splash; Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN SWITZERLAND. ON JULY 17TH 2025, THE MANUFACTURER GOT THE INFORMATION THAT THE WATER SACHET INCLUDED IN THE PRIMARY PACKAGE HAD A WEAK SEAL AND THAT THE WATER SPRAYED OUT. THE FAULT WAS OBSERVED PRIOR TO USE. NO FURTHER INFORMATION AND NO PHOTOS WHERE AVAILABLE. UP ON ARRIVAL OF PRODUCTS RETURNED BY THE USER ON AUGUST 29TH, IT WAS MADE CLEAR THAT THE WELD OF THE PRIMARY PACKAGE WAS DAMAGED, HENCE COMPROMISING THE STERILE BARRIER, THIS DAY IS THE MANUFACTURER AWARENESS DATE OF REPORTABILITY. THE PATIENT DID NOT USE THE CATHETERS AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025041 ↗
• MalfunctionJan 9, 2025Device Handling Problem; Device Handling Problem

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN UNITED KINGDOM. A MALE PATIENT HAS BEEN USING, A STERILE, SINGLE-USE INTERMITTENT URINARY CATHETER LOFRIC ORIGO NELATON (40 CM, CH14). ON (B)(6) 2024, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT HE HAD PROBLEMS TO GET THE DEVICE OUT OF THE PACKAGING SINCE THE DEVICE WAS STUCK IN THE PACKAGE. THE PATIENT ALSO REPORTED THAT HE HAS GOT AN INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 21109566 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD MAN WITH AN ENLARGED PROSTATE HAD PREVIOUSLY USED THE UROLIFT SYSTEM, A NON-INVASIVE TREATMENT FOR BPH THAT HELPS REDUCE PROSTATE SWELLING AND IMPROVE URINE FLOW. HE REQUIRED INTERMITTENT CATHETERIZATION (IC) ALONGSIDE THIS PROCEDURE. ON (B)(6) 2024, THE PATIENT INFORMED THE MANUFACTURER THAT HE HAD ENCOUNTERED "BURS" AT THE TIP OF THE CATHETERS ON TWO OCCASIONS. THE FIRST TIME HE NOTICED A "BUR," HE DISCARDED THE CATHETER AND USED A NEW ONE. THE SECOND TIME, HE DID NOT NOTICE THE "BUR" BECAUSE IT WAS NIGHTTIME. WHILE CATHETERIZING THAT NIGHT, HE FELT RESISTANCE AND HAD A STRONG URGE TO URINATE, SO HE "PUSHED HARDER," WHICH CAUSED BLEEDING. HE WENT TO THE EMERGENCY ROOM AT THE (B)(6) HOSPITAL AND WAS ADMITTED FOR 4 OR 5 DAYS. DURING HIS HOSPITAL STAY, THEY PERFORMED A PROCEDURE TO REMOVE THE UROLIFT AND STOP THE BLEEDING. HE MENTIONED THAT HE WAS "OUT OF IT" DURING HIS STAY. THE HOSPITAL ADVISED HIM TO STOP USING LOFRIC CATHETERS AND PROVIDED ALTERNATIVE CATHETERS. ACCORDING TO THE PATIENT, DUE TO THIS INCIDENT AND THE DAMAGE CAUSED BY THE CATHETER, HE WILL NOW HAVE TO SELF-CATHETERIZE FOR THE REST OF HIS LIFE. HE ALSO STATED THAT HIS HEALTHCARE PROVIDER NEVER PROVIDE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20682238 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED BLEEDING FOR SEVERAL DAYS AFTER USING INTERMITTENT URINARY CATHETER (LOFRIC ORIGO). HE IS AN EXPERIENCED USER AND HAS USED LOFRIC ORIGO DURING SEVERAL YEARS. STARTING AROUND (B)(6) 2024 PATIENT HAVE HAD A FEW BOUTS OF BLEEDING PROBABLY DUE TO ROUGH EDGES AROUND THE CATHETER HOLE ACCORDING TO THE PATIENT HIMSELF. THE LAST BOUT OF BLEEDING LASTED OVER FOUR DAYS. THE PATIENT ALSO CLAIMS THAT THE COATING OF THE CATHETER IS NOT A "SLIPPERY" AS IT HAS BEEN IN THE PAST. URINALYSIS AND URINE CULTURES HAS BEEN PERFORMED, ORDERED BY PATIENT'S UROLOGIST. BOTH WERE NEGATIVE. LAST BLEEDING, WHICH WAS MODERATE, LASTED FOR 4 DAYS. AT THAT TIME, PATIENT VISITED HIS UROLOGIST'S OFFICE AND URINALYSIS AND AN URINE CULTURE WAS PERFORMED. BOTH WERE NEGATIVE AND NO OBSTRUCTIONS WAS DETECTED IN URETHRA. AFTER EXAIMINATION THE PATIENT WAS GIVEN NEW CATHETER SAMPLES OF A DIFFERENT BRAND TO TRY.

  Patient problems: Genital Bleeding

  MAUDE report 19631439 ↗