GentleCath Hydrophilic 509001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387031873), received between May 19, 2025 and Dec 9, 2025 — classified as 2 injuries.

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 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A MALE PATIENT HAS BEEN USING A URINARY CATHETER, GENTLECATH HYDROPHILIC TIEMANN (COUDÉ) MALE 16'' 14FR, FOR A YEAR DUE TO RETENTION FROM BLADDER MUSCLE DYSFUNCTION. HE STARTED BY LEARNING CIC (CLEAN INTERMITTENT CATHETERIZATION) WITH STRAIGTH TIP CATHETERS, AND WHEN HE HAD DIFFICULTY PASSING THE PROSTATE, HIS DOCTOR HAD HIM TRY COUDÉ-TIP CATHETERS. HIS USUAL ROUTINE HAS BEEN TO USE TWO COUDÉ-TIP CATHETERS (TIEMANN) AND ONE STRAIGHT TIP CATHETER (NELATON) THROUGHOUT THE DAY. HE IS FAMILIARIZED HOW TO USE COUDÉ-TIP CATHETERS. HE STATED THAT ONE OF THE CATHETERS FROM CUSTOMER BOX WITH LOT NUMBER 668379 THAT HE WAS USING AT THIS TIME "MAY HAD A LITTLE TO MUCH BEND AT THE END, NOT SURE, OR SOMETHING SHARP". HOWEVER, HE DID NOT CHECK THE CATHETER TIP TO SEE WHAT WAS WRONG WITH IT. UPON INSERTION, HE FELT SOMETHING SHARP ON THE SHAFT JUST BEFORE IT INTERED THE BLADDER. HE THOUGHT SOMETHING MIGHT BE STUCK AT THE INSERTION SITE, SO HE WITHDRAWS THE CATHETER AND REINSERTED IT AND EMPTIED HIS BLADDER. WHEN HE EMPTIED HIS BLADDER, HE NOTICED HEAVY BLEEDING. THE BLEEDING WAS ALARMING ENOUGH FOR HIM THAT HE THOUGHT HE NEEDED TO GO TO THE EMERGENCY ROOM (ER). HOWEVER, HE WAS ABLE TO CALL HIS URO

  Patient problems: Genital Bleeding

  MAUDE report 23754716 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE USER WHO IS RELATIVELY NEW IN INTERMITTENT CATHETERIZATION (LESS THAN YEAR) REPORTED THAT HE EXPERIENCED A MAJOR BLEEDING AFTER USE OF AN INTERMITTENT URINARY CATHETER, GENTLECATH CATHETER. ON EVENING ON (B)(6), WHEN HE WAS GOING TO CATHETERIZE HIMSELF HE FELT LIKE THE CATHETER WAS A "LITTLE SHARP" SO HE INSERTED THE CATHETER SLOWLY AND EVERYTHING WENT WELL AND HE WENT TO BED. IN THE MIDDLE OF THE NIGHT, HE HAD AN ERECTION AND HAD A MAJOR BLEEDING FROM HIS PENIS. AS SOON AS HIS ERECTION WENT DOWN THE BLEEDING STOPPED. USER INFORMED HIS MD OFFICE OF HIS BLEEDING AS HE WOULD LIKE TO BE SEEN. THE USER HAS NOT COMMENTED ON WHAT THE MD OFFICE RESPONDED WITH. ON (B)(6) 2025, HE HAD A URINE CULTURE AND IT SHOWED POSITIVE FOR UTI AND PLACED ON AN ALTERNATIVE ANTIBIOTIC TREATMENT. HE WAS ON HIS LAST TWO DOSES WHEN HE HAD THE LARGE BLEEDING EVENT AS DESCRIBED ABOVE. USER HAS A HISTORY OF HOLEP PROCEDURE PERFORMED ON (B)(6) 2024 AND THEN HAD A SECOND SURGERY ON (B)(6) 2025 TO REMOVE SCAR TISSUE/STRICTURE THAT HAD FORMED AFTER THE SURGERY ON (B)(6) 2024. HE STATES THAT HE HAD A PROCEDURE THAT MOVED PART OF HIS BLADDER NECK OVER THE STRICTURE. PRIOR TO HIS SURGERY ON (B)(6) 2025, HE WAS

  Patient problems: Genital Bleeding

  MAUDE report 22042124 ↗