GENTLECATH GLIDE 421570Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 30768455143574), received between Mar 9, 2023 and Mar 12, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Unsealed Device Packaging

  END USER REPORTS "ONE CATHETER SEALED IN THE SEAL". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583393 ↗
• MalfunctionMar 9, 2026Packaging Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547521 ↗
• MalfunctionMar 3, 2026Entrapment of Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497852 ↗
• MalfunctionJan 28, 2026Unsealed Device Packaging

  IT WAS REPORTED "THE CATHETER TIP IS CRIMPED TOGETHER WITH THE PACKAGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198400 ↗
• MalfunctionSep 3, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  IT WAS REPORTED "THE POUCH IN THE PRODUCT IS ALREADY TORN AND CONTAMINATED." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951339 ↗
• MalfunctionSep 3, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  IT WAS REPORTED "THE POUCH IN THE PRODUCT IS ALREADY TORN AND CONTAMINATED." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951330 ↗
• MalfunctionDec 19, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED " THE CATHETER TIP IS SEALED WITH POUCH PACKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354392 ↗
• InjuryNov 30, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 18237173 ↗
• InjuryNov 30, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  END USER STATES "SHE CATHS DUE TO RETENTION FROM BLADDER MUSCLE DYSFUNCTION. SHE CATHS 6-7 X A DAY AND IS NOT NEW TO CATHING. SHE PREVIOUSLY USED THE CURE T10 WITHOUT CONCERNS AND THEN DUE TO INSURANCE REASONS WAS SWITCHED TO THE GC GLIDE 10 FR FEMALE. GC GLIDE INITIALLY WORKED WELL FOR MONTHS BUT SHE HAS NOTICED A CHANGE IN THE LAST 2 MONTHS ONLY THEY ARE NOT WORKING WELL FOR HER. SHE STATES SINCE SHE STARTED TO NOTICE THE COLOR OF THE CATHETER CHANGE TO YELLOW" (IT WAS EXPLAINED TO HER THAT CHANGE WAS MADE DUE TO THE CHANGE IN STERILIZATION PROCESS). END USER STATES "THEY FEEL DRY/ INADEQUATE LUBRICATION AFTER ACTIVATION OF WATER SACHET. SHE SAID AFTER SHE FINALLY REMOVES THE CATHETER FROM URETHRA SHE WILL RUN HER HAND DOWN THEM AND THEY ALL FEEL DRY AFFECTING THE ENTIRE CATHETER EVEN NEAR EYELETS. OFTEN THEY WILL "GET STUCK" IN URETHRA AS SHE REMOVES THEM OUT WHICH PREVIOUSLY WOULD NEVER OCCUR WITH THESE. SHE SAID IT SOMETIMES HAS CAUSED HER PAIN TO THE POINT OF CRYING. SHE ENSURED SHE USES THEM WITHIN THE 1-2 TIME FRAME AFTER THE WATER SACHET IS BURST TO DRAIN HERSELF. IN OCTOBER, THIS PAIN DID NOT SUBSIDE. PAIN AND IRRITATION INCREASED SO SHE WENT INTO URGENT CARE WHERE THEY

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 18237168 ↗
• MalfunctionSep 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816304 ↗
• MalfunctionSep 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816303 ↗
• MalfunctionSep 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816302 ↗
• MalfunctionSep 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816301 ↗
• MalfunctionSep 26, 2023Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816300 ↗
• MalfunctionSep 14, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "THAT THE CATHETER TIP IS SEALED IN POUCH PACKAGE." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744167 ↗
• MalfunctionAug 17, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED " THE CATHETER TIP IS SEALED WITH SEALING PART OF PACKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563374 ↗
• MalfunctionAug 17, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED " THE CATHETER TIP IS SEALED WITH SEALING PART OF PACKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563372 ↗
• MalfunctionJun 5, 2023Unsealed Device Packaging; Unsealed Device Packaging

  END USER REPORTED "THE CATHETER TIP IS WELDED WITH PACKAGE SEALING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17064424 ↗
• MalfunctionMar 9, 2023Unsealed Device Packaging; Unsealed Device Packaging

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513086 ↗