GENTLECATH GLIDE 421573Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30768455143604), received between Nov 22, 2017 and Jan 16, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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.

• MalfunctionJan 16, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE NURSE COMPLAINED REGARDING THE DRESSING CONTAMINATED WITH HAIR, WHILE ATTENDING TO THE PATIENT AND COVERING THE WOUNDS, THE TOTAL OF ONE UNIT WAS AFFECTED. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092121 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL STUDY FOR GENTLECATH GLIDE CATHETERS, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION (UTI). THE PATIENT STARTED USING GENTLECATH GLIDE CATHETERS ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS OF A (UTI). THE PATIENT WAS REFERRED FOR AN OFFICE VISIT AND WAS SEEN ON (B)(6) 2017. IT WAS NOTED THAT THE PATIENT CONTINUED TO USE THE GENTLECATH FROM (B)(6) 2017 UNTIL THAT OFFICE VISIT. THE GENTLECATH GLIDE CATHETERS WERE DISCONTINUED AND THE PATIENT WAS TREATED WITH LEVOFLOXACIN (500 MG). NO URINE CULTURES WERE PERFORMED AND THE PATIENT¿S SYMPTOMS RESOLVED WITH THE TREATMENT. THE PRINCIPLE INVESTIGATOR (PI) OF THE CLINICAL TRIAL, REPORTED THAT 2 WEEKS WITHOUT INFECTION IS A GOOD RESULT FOR THIS PATIENT. IT WAS ALSO NOTED THAT THE PATIENT STARTED PERFORMING SELF-CATHERIZATION ON (B)(6) 2017 AND HAS HAD URINARY TRACT INFECTIONS VERY OFTEN IN THE PAST WHILE USING ANOTHER BRAND CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT USING THE GENTLECATH GLIDE CATHETER PRIOR TO THE CLINICAL TRIAL STUDY. THE MOST RECENT INFECTION WAS PRIOR TO THE START OF THE STUDY WAS ON A VISIT (B)(6) 2017, AND DETERMINED DURING A UR

  Patient problems: Urinary Tract Infection

  MAUDE report 7052660 ↗