GENTLECATH 510601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455204816), received between Jan 6, 2026 and Jan 6, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE CATHS 6 X DAY. SHE USES GCAFW OUT OF HOME AND GC GLIDE AT HOME. "EARLY LAST YEAR (B)(6) 2025 SHE WAS HAVING URINE LEAKAGE HAVING TO CHANGE PADS FREQUENTLY AS WELL AS WAS GETTING UTIS SHE NEEDED ANTIBIOTIC TREATMENT FOR. SHE SAW A UROLOGIST AS ADVISED BY HER PCP AND WHICH RAN SEVERAL TESTS INCLUDING A URODYNAMICS TEST WHICH SHOWED HER BLADDER IS NOT FULLY EMPTYING. SHE WAS GIVEN ESTRADIOL VAGINAL CREAM AND IN (B)(6) 2025 ADVISED TO START CIC WHICH SHE HAS BEEN DOING SUCCESSFULLY 6 X A DAY. SHE INITIALLY TRIALED MANY OTHER CATHETERS WHEN SHE FIRST STARTED CIC BUT PREFER OUR GC HYDROPHILIC CATHETERS. IN SUMMER 2025 HER UTIS STARTED OCCURRING AGAIN, THIS TIME WHILE SHE WAS CATHING AND BECAME RECURRENT SHE SAID IT WAS "1 AFTER THE OTHER." HER SYMPTOMS AREA ALWAYS BURNING SENSATION, URGENCY AND CLOUDY URINE AND HAS A DISCOMFORT WITH CATHING AT END OF BLADDER DRAINAGE. HER UROLOGIST STARTED HER ON CRANBERRY SUPPLEMENTS AND TREATED HER WITH ANTIBIOTICS EACH TIME. SHE SAID HER URINE CULTURES SHOWED E. COLI AT FIRST BUT THEN CANNOT REMEMBER THE BACTERIAL RESULTS OF THE OTHER URINE CULTURES SHE NEEDED ANTIBIOTIC TREATMENTS FOR AND THINK THEY WERE DIFFERENT FROM E. COLI. S

  Patient problems: Urinary Tract Infection

  MAUDE report 23974778 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  END USER REPORTS SHE CATHS 6 X DAY. SHE USES GCAFW OUT OF HOME AND GC GLIDE AT HOME. "EARLY LAST YEAR (B)(6) 2025 SHE WAS HAVING URINE LEAKAGE HAVING TO CHANGE PADS FREQUENTLY AS WELL AS WAS GETTING UTIS SHE NEEDED ANTIBIOTIC TREATMENT FOR. SHE SAW A UROLOGIST AS ADVISED BY HER PCP AND WHICH RAN SEVERAL TESTS INCLUDING A URODYNAMICS TEST WHICH SHOWED HER BLADDER IS NOT FULLY EMPTYING. SHE WAS GIVEN ESTRADIOL VAGINAL CREAM AND IN (B)(6) 2025 ADVISED TO START CIC WHICH SHE HAS BEEN DOING SUCCESSFULLY 6 X A DAY. SHE INITIALLY TRIALED MANY OTHER CATHETERS WHEN SHE FIRST STARTED CIC BUT PREFER OUR GC HYDROPHILIC CATHETERS. IN SUMMER 2025 HER UTIS STARTED OCCURRING AGAIN, THIS TIME WHILE SHE WAS CATHING AND BECAME RECURRENT SHE SAID IT WAS "1 AFTER THE OTHER." HER SYMPTOMS AREA ALWAYS BURNING SENSATION, URGENCY AND CLOUDY URINE AND HAS A DISCOMFORT WITH CATHING AT END OF BLADDER DRAINAGE. HER UROLOGIST STARTED HER ON CRANBERRY SUPPLEMENTS AND TREATED HER WITH ANTIBIOTICS EACH TIME. SHE SAID HER URINE CULTURES SHOWED E. COLI AT FIRST BUT THEN CANNOT REMEMBER THE BACTERIAL RESULTS OF THE OTHER URINE CULTURES SHE NEEDED ANTIBIOTIC TREATMENTS FOR AND THINK THEY WERE DIFFERENT FROM E. COLI. S

  Patient problems: Urinary Tract Infection

  MAUDE report 23974777 ↗