LoFric® Origo™ 44416 (REF 4441640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387043456), received between Jan 9, 2025 and Dec 11, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS ADVERSE EVENT OCCURRED IN THE USA. A MALE PATIENT WITH THE MEDICAL CONDITION URINARY RETENTION, BPH, CONSTIPATION AND DIABETES, HAS BEEN USING A STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER, LOFRIC ORIGO COUDÉ (16'' 16FR). ON (B)(6) 2025, THE PATIENT INFORMED THE MANUFACTURER REPRESENTATIVE THAT HE HAD AN INCIDENT WITH THE CATHETER 2 DAYS AGO. THE PATIENT, WHO IS NEW TO THE THERAPY INTERMITTENT CATHETERIZATION, HAD PROBLEMS INSERTING THE CATHETER AND HE EXPERIENCED IT VERY RESISTANT TO INSERT. HE STATED HE DID EXPERIENCE PAIN WHEN HE MET THE RESISTANCE. AFTER HE HAD REMOVED THE CATHETER, SEVERE BLEEDING OCCURRED (PROBABLY A FRUIT JUICE GLASS SIZE OF BLOOD, ACCORDING TO THE PATIENT). THE PATIENT WENT TO THE HOSPITAL EMERGENCY DUE TO THE BLEEDING. HE STATED THAT THE HOSPITAL PLACED A FOLEY CATHETER AND TOLD HIM THAT HIS PROSTATE WAS SWOLLEN AND "PINCHED OFF THE URETHRA." HE WAS THEN RELEASED HOME. THE ONLY TREATMENT HE HAD WAS A FOLEY CATHETER INSERTED. HE STATED HE WILL HAVE THE FOLEY UNTIL ON (B)(6) AS THAT'S THE SOONEST THE UROLOGIST COULD SEE HIM. THE MANUFACTURER REPRESENTATIVE PROVIDED EDUCATION FOR IC TECHNIQUE, WAYS TO RELAX THE SPHINCTER AND EASE THE CATHETER IN,

  Patient problems: Inflammation

  MAUDE report 23776510 ↗
• MalfunctionJan 9, 2025Product Quality Problem; Product Quality Problem

  A 73-YEAR-OLD MAN HAS BEEN USING LOFRIC ORIGO WITH TIEMANN (COUDE) TIP DUE TO PROBLEMS WITH URINARY RETENTION (NEUROGENIC BLADDER) AS WELL AS ENLARGED PROSTATE. THE USER EXPERIENCED BLOOD IN THE URINE AND ON THE TIP OF THE CATHETER AFTER USE. HE SOUGHT MEDICAL ATTENTION AND HAD A URINE CULTURE DONE TO DETERMINE THE BACTERIA COUNT. TO TREAT A URINARY TRACT INFECTION (UTI), HE WAS PRESCRIBED ANTIBIOTICS 3 TIMES DAILY FOR 14 DAYS. IN ADDITION, HE WILL TAKE LOW DOSE ANTIBIOTIC 1 TIMES DAILY INDEFINITELY TO FURTHER REDUCE RISKS OF UTI'S. NO OTHER TESTING, PROCEDURES, OR TREATMENTS WERE PERFORMED. ACCORDING TO THE PATIENT THE HARM IS RELATED DUE TO MISALIGNMENT BETWEEN THE CATHETER BENT TIP AND THE INDICATOR ON THE CATHETER FUNNEL WHICH HAS SCORED HIS URETHRA AND LET TO UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 21109464 ↗