GENTLECATH 510602Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455204847), received between Aug 5, 2025 and Apr 8, 2026 — classified as 2 injuries.

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

• InjuryApr 8, 2026Device Handling Problem

  END USER STATES SHE "WAS GIVEN SAMPLES OF OUR (B)(6) FR AND SHOWN HOW TO CIC AT UROLOGISTS OFFICE AND ADVISED PERFORMING CIC ONCE A DAY, AND AT NIGHT BEFORE BED DUE TO URINARY RETENTION, AS SHE HAS BEEN HAVING A WEAK STREAM FOR A WHILE NOW ESPECIALLY AT NIGHT. SHE SAID PREVIOUSLY IN HER LIFETIME (BEFORE EVEN STARTING CIC) SHE HAS HAD AROUND "5 OR SO" UTIS. SINCE SHE JUST STARTED CIC, THIS IS THE FIRST TIME SHE GOT A UTI WHICH STARTED JUST A FEW DAYS AFTER STARTING CIC. SHE REALLY ISN'T SURE WHERE THE UTI CAME FROM. SHE SAID AT HOME SHE STRUGGLED WITH FINDING THE RIGHT SPOT TO GET IT IN HER URETHRA WHEN SHE FIRST ATTEMPTED THIS AT HOME. SHE HAD TO USE SEVERAL TO FIGURE IT OUT AS "SHE PROBED AROUND A LOT" AND WAS A LITTLE SORE DOWN THERE FROM TRYING WITH THE CATHETER SAMPLES. SHE HAD TRIED TO USE A LIGHT ON THE FLOOR BUT IT WAS HARD FOR HER TO HOLD A MIRROR AT THE SAME TIME TO SEE HER URETERAL OPENING WELL. WHEN HER SUPPLIER CALLED HER TO SET HER UP WITH SUPPLIES, SHE RELAYED THIS STRUGGLE TO THEM AND THEY EVEN SENT HER A LEG MIRROR WHICH JUST ARRIVED YESTERDAY IN HER FIRST FULL ORDER. SHE SAID SHE WAS FINALLY, ACTUALLY, SUCCESSFUL PRIOR TO NEEDING TO USE IT. SHE SAID ON HER 4TH TIME

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 24817773 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES "NO DEFECTS NOTED AT ALL WITH THE PRODUCT. SHE DID STATE SHE DID HAVE 2 UTIS WHILE USING IT BUT DID NOT FEEL IT WAS THE ONLY POSSIBLE CAUSE TO BLAME FOR HER UTIS, RATHER IT DID NOT WORK FOR HER ANATOMY TO FULLY DRAIN HER AS WELL COMPARED TO HER PRIOR CATHETER (THE INFYNA CHIC) AND THINKS THIS MAY HAVE LED TO THOSE UTIS WHILE USING THIS PRODUCT. CONSUMER STATES SHE IS ALMOST 80 YR OLD FEMALE CATHING FOR THE LAST YEAR, 2-3 TIMES A DAY. SHE STATES HER BLADDER LOOKS LIKE THE CRATERS OF THE MOON" HAS MULTIPLE DIVERTICULI, STATING SHE HAS MULTIPLE BLADDER AND PELVIC ISSUES. SHE REITERATED MULTIPLE TIMES ON OUR CALL SHE DID NOT FEEL THE CATH IS DEFECTED IT JUST DIDN'T WORK FOR HER AND IT JUST DIDN'T DRAIN HER AS FULLY AS HER OTHER CATHETER THUS POSSIBLY LEADING TO 2 UTIS." SHE WAS USED TO USING THE INFYNA CHIC CATHETER AND PER HER SUPPLIER "SHE TRIED THE GCAFW FOR ABOUT 2 MONTHS. SHE STATES SHE HAS ALWAYS GOTTEN RECURRENT UTI INFECTIONS, EVEN BEFORE TRIALING THIS GCAFW CATHETER. SHE WANTED TO GIVE IT A GOOD TRIAL RUN BUT DIDN'T FEEL IT WAS THE BEST ONE FOR HER. SHE SAID SHE FELT LIKE THIS ONE JUST DIDN'T DRAIN HER AS COMPLETELY AS THE INFYNA CHIC DID DESPITE BEING ABOUT TH

  Patient problems: Urinary Tract Infection

  MAUDE report 22714038 ↗