GENTLECATH 501023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455145607), received between Sep 11, 2025 and Oct 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (2 reports).

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.

• InjuryOct 24, 2025Off-Label Use; Device Handling Problem; Off-Label Use; Device Handling Problem

  END USER STATES SHE "USED TO BE A NURSE AT (B)(6) HOSPITAL IN (B)(6)". SHE HAS BEEN USING THIS CATHETER FOR "4 YEARS AND HAS BEEN TESTING POSITIVE FOR LEUCOCYTES ON AND OFF FOR 4 YEARS. SHE SPOKE WITH HER UROLOGIST AND WAS TOLD TO STOP USING THE UNCOATED CATHETERS AS THIS IS THE REASON FOR THE POSITIVE LEUCOCYTES IN HER URINE. SHE IS NEGATIVE FOR NITRATES. SHE HAS NO SIGNS OF UTI BUT DID GO ON ANTIBIOTICS AT SOME POINT. SHE DOES NOT USE A LUBRICANT WITH THE UNCOATED CATHETERS BECAUSE OF THE MESS IT CAUSES AND SAYS THIS METHOD IS A HIGH-RISK METHOD FOR UTI. SHE ALSO FINDS THESE UNCOATED CATHETERS AND LUBRICANTS DIFFICULT FOR TRAVELLING." PER ADDITIONAL INFORMATION RECEIVED "THE END USER CLARIFIED THAT SHE DID NOT TAKE THE ANTIBIOTICS WHEN THE CULTURE WAS NEGATIVE HOWEVER SHE IS ON ANTIBIOTICS FREQUENTLY BECAUSE SHE FREQUENTLY GETS UTI'S. SHE SAYS THAT SHE IS AWARE OF THE RISK OF NOT USING THE LUBRICANTS WITH THE UNCOATED CATHETERS." FURTHER INFORMATION WAS RECEIVED 17 OCT 2025 THAT END USER STATES "SHE HAS HAD X14 UTI THIS PAST YEAR AND ALL WERE TREATED WITH ANTIBIOTICS." UNKNOWN LOT NUMBERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 23378126 ↗
• InjurySep 11, 2025Off-Label Use; Device Handling Problem; Off-Label Use; Device Handling Problem

  END USE STATES SHE "USED TO BE A NURSE AT (B)(6) HOSPITAL IN (B)(6)". SHE HAS BEEN USING THIS CATHETER FOR "4 YEARS AND HAS BEEN TESTING POSITIVE FOR LEUCOCYTES ON AND OFF FOR 4 YEARS. SHE SPOKE WITH HER UROLOGIST AND WAS TOLD TO STOP USING THE UNCOATED CATHETERS AS THIS IS THE REASON FOR THE POSITIVE LEUCOCYTES IN HER URINE. SHE IS NEGATIVE FOR NITRATES. SHE HAS NO SIGNS OF UTI BUT DID GO ON ANTIBIOTICS AT SOME POINT. SHE DOES NOT USE A LUBRICANT WITH THE UNCOATED CATHETERS BECAUSE OF THE MESS IT CAUSES AND SAYS THIS METHOD IS A HIGH-RISK METHOD FOR UTI. SHE ALSO FINDS THESE UNCOATED CATHETERS AND LUBRICANTS DIFFICULT FOR TRAVELLING." PER ADDITIONAL INFORMATION RECEIVED "THE END USER CLARIFIED THAT SHE DID NOT TAKE THE ANTIBIOTICS WHEN THE CULTURE WAS NEGATIVE HOWEVER SHE IS ON ANTIBIOTICS FREQUENTLY BECAUSE SHE FREQUENTLY GETS UTI'S. SHE SAYS THAT SHE IS AWARE OF THE RISK OF NOT USING THE LUBRICANTS WITH THE UNCOATED CATHETERS."

  Patient problems: Urinary Tract Infection

  MAUDE report 23025189 ↗