LoFric® 40012 (REF 4001240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07333387033433), received between Mar 21, 2025 and Feb 27, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 16, 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.

• MalfunctionFeb 27, 2026Delivered as Unsterile Product

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN ITALY. A MALE PATIENT HAS BEEN USING, A STERILE, SINGLE-USE INTERMITTENT URINARY CATHETERS LOFRIC NELATON (40CM, CH12). ON (B)(6) 2026, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT THE END OF THE PRIMARY PACKAGE WAS NOT SEALED COMPLETELY, COMPROMISING THE STERILE BARRIER OF THE PRODUCT. THE PATIENT REPORTED THAT HE HAD USED THREE PRODUCTS WITH THIS MAL-FUNCTION. FURTHER THE PATIENT REPORTED THAT HE HAD DISCARDED THE USED PRODUCTS AND THAT HE WILL RETURN THE REMAINING PRODUCTS TO THE MANUFACTURER. THE PATIENT DID NOT SUFFER ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468581 ↗
• InjuryDec 11, 2025Material Deformation; Material Deformation

  ADVERSE EVENT OCCURRED OUTSIDE US, IN FINLAND, WHERE A MALE PATIENT OF 76 YEARS OLD CATHETERIZED HIMSELF IN THE EVENING (8:15 PM) ON (B)(6). WHEN THE CATHETER WAS INSERTED INTO THE URETHRA, A STABBING PAIN WAS FELT. THE PATIENT EXAMINED THE CATHETER AFTER IT HAD BEEN PULLED OUT. THE PATIENT NOTED A SHARP EDGE ON THE CATHETER. AFTER THE EVENT, HE EXPERIENCED A HINT OF REDNESS AND AN INTENSIFIED PAIN. AFTER 3.5 HOURS, THE PATIENT BEGAN TO FEEL UNWELL AND HAD CHILLS. THE PATIENT MEASURED THE FEVER AT 38.4° C AND AN HOUR LATER IT WAS 38.8° C. THE PATIENT ALSO MEASURED HIS BLOOD PRESSURE WHICH SHOWED AN UPPER VALUE OF 198, A LOWER VALUE OF 154, A PULSE OF 205 BEATS/MINUTE. HIS NORMAL VALUE IS AN UPPER VALUE OF 100-120, AND A LOWER VALUE OF 50-70, WITH A PULSE OF 45-60 BEATS/MINUTE. THE FOLLOWING MORNING, THE PATIENT CALLED HIS HEALTH CENTER AND WAS INSTRUCTED TO GO TO THE HOSPITAL. AT THE HOSPITAL, IT WAS CONCLUDED THAT HIS CRP VALUE WAS ELEVATED, AND HE HAD AN UTI (URINARY TRACT INFECTION). THE PATIENT WAS DISCHARGED FROM THE ER SAME DAY WITH ANTIBIOTICS AND PAIN MEDICATION. AFTER 1,5 DAY THE PATIENT FELT BETTER AND HIS CONDITION IS NOW GOOD. THE PATIENT HAS BEEN CATHETERIZING HIMSELF

  Patient problems: Alteration in Body Temperature; Chills; Urinary Tract Infection

  MAUDE report 23777245 ↗
• InjuryMar 21, 2025Patient-Device Incompatibility; Device Handling Problem; Patient-Device Incompatibility; Device Handling Problem

  ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. A USER REPORT FROM THE YELLOW CARD TEAM WAS RECEIVED BY MANUFACTURER ON (B)(6). THE INFORMATION IN THE USER REPORT WAS LIMITED TO "THE PATIENT STATES THAT THE DEVICE CAUSED IRRITATION TO THE URETHRA". AFTER SEVERAL ATTEMPTS, WELLSPECT WAS ABLE TO GET IN CONTACT WITH THE PATIENT IN QUESTION. HE IS A 71-YEAR-OLD MALE WITH DEMENTIA AND RECURRENT UTIS. HE ALSO PASSED KIDNEY STONES 4-5 WEEKS AGO. THE PATIENT HAS BEEN PERFORMING INTERMITTENT SELF CATHETERIZATION (ISC) FOR ABOUT 12 YEARS. THE PATIENT SAID THAT THE CATHETER FELT ROUGH AND HE EXPERIENCED BLEEDING ON WITHDRAWAL, HE NOTICED BLOOD IN THE TOILET, BUT NO BLOOD ON THE CATHETER. THE BLEEDING HAS NOW DECREASED. HE SPOKE WITH HIS GP BUT WAS NOT HOSPITALIZED NOT TREATED. CURRENTLY THE PATIENT IS WASHING AND REUSING TWO CATHETERS THAT HE THINKS IS SMOOTH, LIKELY FROM THE SAME LOT AS THE ONE THAT FELT ROUGH. THE PATIENT HAS DISCARDED THE ROUGH CATHETER.

  Patient problems: Burning Sensation; Genital Bleeding

  MAUDE report 21661315 ↗