GENTLECATH 501022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455145591), received between Feb 10, 2025 and Feb 10, 2025 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTED UNKNOWN QTY, UNKNOWN MUS, UNKNOWN LOTS OVER THE PAST FEW YEARS - MULTIPLE UTIS WITH USE. SHE STATES SHE HAS BEEN CATHING FOR YEARS, DUE TO SCAR TISSUE IN HER URETHRA AS MD ADVISED CATHING 1 X A WEEK TO KEEP HER URETHRAL SCAR TISSUE DILATED. SHE SAID THROUGHOUT THE YEARS SHE HAD TO CATH AND WOULD CONSTANTLY GET UTIS - SHE COULD NOT NAME HOW MANY UTIS SHE HAD BUT IT WAS NEARLY EVERY MONTH OR A LITTLE LONGER THAN A MONTH. HER MAIN UTI SYMPTOM WAS A CONSTANT FEELING OF PRESSURE. SHE WOULD OFTEN GO TO URGENT CARES TO GET URINE SPECIMENS, GET DIAGNOSED WITH UTIS AND TREATMENTS WITH ANTIBIOTICS AND AT TIMES OVER THE COUNTER AZO. SHE WAS NEVER PLACED ON ANY PROPHYLACTIC ANTIBIOTICS. SHE STATED SHE IS NOT BLAMING THE CATHETER FOR HER UTIS. NO PHOTO AVAILABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 21351405 ↗