GENTLECATH GLIDE 421567Recalls & reported problems

Summary

The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 30768455143543), received between Oct 21, 2022 and Sep 22, 2026 — classified as 19 injuries, 323 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (268 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 25 most recent of 342 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853404 ↗
• MalfunctionSep 4, 2026Entrapment of Device

  To date no additional patient or event details have been received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611912 ↗
• MalfunctionSep 4, 2026Entrapment of Device

  To date no additional patient or event details have been received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611911 ↗
• MalfunctionApr 1, 2026Packaging Problem

  END USER REPORTS SOME OF THE PACKAGING WASN¿T SEALED CORRECTLY SO WHEN THE WATER SACHET WAS POPPED IT WOULD LEAK. NO PHOTO WAS AVAILABLE. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR COVERS THE UNKNOWN QTY FROM THIS LOT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754271 ↗
• MalfunctionFeb 26, 2026Packaging Problem

  END USER REPORTS THE PACKAGING OF THE GLIDE CATHETER SPLITS ON THE SIDE. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR COVERS THE UNKNOWN LOT NUMBERS AND UNKNOWN QUANTITY ASSOCIATED WITH THE REPORTED DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461901 ↗
• MalfunctionFeb 26, 2026Packaging Problem

  END USER REPORTS THE PACKAGING OF THE GLIDE CATHETER SPLITS ON THE SIDE. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461897 ↗
• MalfunctionFeb 9, 2026Sharp Edges

  END USER STATES "HE CAN FEEL A BURR NEAR THE EYELET FOR HIS GC GLIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291803 ↗
• MalfunctionFeb 9, 2026Sharp Edges

  END USER STATES "HE CAN FEEL A BURR NEAR THE EYELET FOR HIS GC GLIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291802 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Urinary Tract Infection

  MAUDE report 24023797 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS HE HAS HAD MULTIPLE UTIS OVER THE 5 YRS HE HAS USED THIS CATHETER. HE SAID SINCE HE STARTED CIC 5 YRS AGO, HE HAS HAD UTIS ALMOST EVERY 3 MONTHS. HE SAID ONLY FOR A YEAR HE WAS ON PROPHYLACTIC CIPRO AND HE WAS UTI FREE FOR THAT YEAR HOWEVER HE BECAME ALLERGIC TO CIPRO AND HAD TO DISCONTINUE THAT. HE SAID HIS SYMPTOMS ARE ALWAYS BURNING AND CLOUDY URINE. HIS MD HAS TOLD HIM HIS RECURRENT UTIS ARE MOST LIKELY NOT FROM HIS CATHETERS BUT RATHER FROM A RARE BACTERIUM THAT HAS COLONIZED HIS PROSTATE. HE SAID THE BACTERIA IS A COMMON SKIN BACTERIA CALLED "EPIDERMIDIS" WHICH IS ON THE SKIN AND RARE TO CAUSE A UTI BUT FOR HIM THEY DO AND THE URINE CULTURES SHOW THIS BACTERIUM OVER AND OVER AGAIN FOR HIM. HE SAID USUALLY HIS MD HAS HIM DO A URINE CULTURE AND PRESCRIBE HIM DOXYCYCLINE COURSE FOR A FEW DAYS WHICH HELPS HIM IMMEDIATELY WITHIN 24 - 48 HOURS HE FEELS BETTER HE SAID ON THIS ANTIBIOTIC. HE IS CAREFUL TO FOLLOW ALL HYGIENE PRECAUTIONS, ALWAYS WASHES HANDS, CLEANSES GLANS, ENSURES THE CATHETER STAYS STERILE. HIS MD HAS ADVISED HE WILL NEED SURGERY ON HIS PROSTATE TO HELP REDUCE HIS INFECTIONS BUT SO FAR, HE HAS NOT OPTED TO HAVE THIS DONE. NO ADDITIONAL INFORMATION W

  Patient problems: Urinary Tract Infection

  MAUDE report 23607665 ↗
• MalfunctionNov 14, 2025Sharp Edges; Sharp Edges

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

  Patient problems: Discomfort

  MAUDE report 23556758 ↗
• MalfunctionAug 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922146 ↗
• MalfunctionAug 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS HE HAS USED OUR HYDROPHILIC CATHETERS FOR 5 YEARS. IN THE LAST 2 YEARS HE SAYS HE HAS HAD 4 DEFECTS- LEAK AT THE JOINT OF THE ENVELOPE. THERE WAS NO HARM REPORTED. NO PHOTOS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922145 ↗
• InjuryAug 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922083 ↗
• InjuryAug 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922079 ↗
• MalfunctionJul 1, 2025Sharp Edges; Sharp Edges

  EU REPORTS SHARP EYELETS CUTTING HIM. IT WAS REPORTED THAT 1 OUT OF EVERY 20 CATHETERS (OF THE SAME LOT) HAS BEEN CUTTING, DURING INSERTION BY THE SHARP EYELETS. NO FURTHER INFORMATION IS AVAILABLE. NO PHOTO AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22372364 ↗
• MalfunctionJun 27, 2025Sharp Edges; Sharp Edges

  END USER STATES HE HAS BEEN "CATHING FOR ONLY A MONTHS TIME NOW FOR RETENTION FROM BPH THAT WAS FOUND IN THE ER AS HE HADN'T BEEN ABLE TO VOID FOR A FEW DAYS AND HAD TO GO TO ER. HE SAID HE FEELS LIKE CERTAIN FOODS AFFECT HIS PROSTATE, CAUSING IT TO SWELL AND FELT STRONGLY THAT A "DANDELION SANDWICH" HE ATE CAUSED THAT EPISODE OF RETENTION." HE SAID HE "PREPS THESE CATHETER BY REMOVING THE SILVER WATER AND POURING IN THE WATER TO PREP THE CATHETER. HE ALSO REMOVES THE BLUE NO TOUCH SLEEVE AS HE FEELS HE CANNOT ACCESS ENOUGH OF THE CATHETER." IT WAS EXPLAINED TO HIM THE PROPER WAY TO PREP THE CATHETER PER IFUS AND THAT HE CAN SLIDE THE NO TOUCH SLEEVE UP OVER THE FUNNEL AS WELL. HE SAID SO FAR THIS CATHETER HAS BEEN WORKING WELL FOR HIM AND HE DOES NOT FEEL THAT THE WAY HE PREPPED IT (NOT ACCORDING TO IFUS) HAD ANY IMPACT ON THIS PARTICULAR CONCERN. HE SAID IT SLIGHTLY UNCOMFORTABLE GOING IN THE LENGTH OF HIS URETHRA BUT "KIND OF WORSE ON THE WAY OUT" FEELING IT "SCRAPPING HIM" AND NOTICED HE HAD BLEEDING AFTERWARDS UPON REMOVAL. HE SAID HE FELT THAT CATHETER WITH HIS HANDS UPON REMOVAL AND FELT "JAGGED SPOT AROUND THE HOLES (EYELETS) AND ONE (EYELET) HAD WHAT FELT LIKE A SMALL POIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22344423 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER'S WIFE STATES "WHILE USING THIS PRODUCT HER HUSBAND HAS BEEN DIAGNOSED WITH 2 UTIS BY HIS UROLOGIST AND THINKS THAT IT IS DUE TO THESE ONGOING ISSUES WITH THIS PRODUCT THAT THE CATHETERS ARE TO BLAME FOR THOSE UTIS."

  Patient problems: Urinary Tract Infection

  MAUDE report 21445181 ↗
• MalfunctionFeb 24, 2025Unsealed 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 21445103 ↗
• MalfunctionFeb 24, 2025Unsealed 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 21445101 ↗
• MalfunctionFeb 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445042 ↗
• MalfunctionFeb 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS HE RECEIVED A BOX WHERE THE SEALS ON THE BOTTOM OF INDIVIDUAL CATHETER'S PACKAGING WERE NOT TOGETHER, CATHETER ITSELF STICKING OUT THROUGH THE BOTTOM OF PACKAGING. END USER REPORTS RECEIVING A BOX OF HIS USUAL CATHETERS IN HIS ORDER, AND THAT THE SEALS ON THE BOTTOM OF THE INDIVIDUAL CATHETER'S PACKAGING WERE DEFECTED AS THEY WERE NOT SEALED PROPERLY. THESE HAVE ALREADY BEEN DISCARDED. ALL WERE LIKE THIS IN THIS BOX. HE STATES THE CATHETER ITSELF WAS "POKING OUT" A LITTLE BIT THROUGH THE BOTTOM OF THE PACKAGING'S SEAL ( BY BOTTOM OF PACKAGING HE MEANS THE EYELET END OF THE CATHETER). THE POINT OF THE CATHETER WAS EXPOSED OUT OF THE PACKAGING LIKE THE BOTTOM DID NOT SEAL CORRECTLY OR THE CATHETER WAS DROPPED DOWN IN THE PACKAGING TOO FAR DOWN BEFORE IT WAS SEALED HE SAID. IT DID NOT LOOK LIKE IT WAS TORN IN ANY WAY. THE MU BOX WAS NOT DAMAGED EITHER. NO HARM WAS REPORTED. NO PHOTO AVAILABLE, PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403720 ↗
• MalfunctionFeb 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS HE RECEIVED A BOX WHERE THE SEALS ON THE BOTTOM OF INDIVIDUAL CATHETER'S PACKAGING WERE NOT TOGETHER, CATHETER ITSELF STICKING OUT THROUGH THE BOTTOM OF PACKAGING. END USER REPORTS RECEIVING A BOX OF HIS USUAL CATHETERS IN HIS ORDER, AND THAT THE SEALS ON THE BOTTOM OF THE INDIVIDUAL CATHETER'S PACKAGING WERE DEFECTED AS THEY WERE NOT SEALED PROPERLY. THESE HAVE ALREADY BEEN DISCARDED. ALL WERE LIKE THIS IN THIS BOX. HE STATES THE CATHETER ITSELF WAS "POKING OUT" A LITTLE BIT THROUGH THE BOTTOM OF THE PACKAGING'S SEAL ( BY BOTTOM OF PACKAGING HE MEANS THE EYELET END OF THE CATHETER). THE POINT OF THE CATHETER WAS EXPOSED OUT OF THE PACKAGING LIKE THE BOTTOM DID NOT SEAL CORRECTLY OR THE CATHETER WAS DROPPED DOWN IN THE PACKAGING TOO FAR DOWN BEFORE IT WAS SEALED HE SAID. IT DID NOT LOOK LIKE IT WAS TORN IN ANY WAY. THE MU BOX WAS NOT DAMAGED EITHER. NO HARM WAS REPORTED. NO PHOTO AVAILABLE, PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402918 ↗
• MalfunctionFeb 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS HE RECEIVED A BOX WHERE THE SEALS ON THE BOTTOM OF INDIVIDUAL CATHETER'S PACKAGING WERE NOT TOGETHER, CATHETER ITSELF STICKING OUT THROUGH THE BOTTOM OF PACKAGING. END USER REPORTS RECEIVING A BOX OF HIS USUAL CATHETERS IN HIS ORDER, AND THAT THE SEALS ON THE BOTTOM OF THE INDIVIDUAL CATHETER'S PACKAGING WERE DEFECTED AS THEY WERE NOT SEALED PROPERLY. THESE HAVE ALREADY BEEN DISCARDED. ALL WERE LIKE THIS IN THIS BOX. HE STATES THE CATHETER ITSELF WAS "POKING OUT" A LITTLE BIT THROUGH THE BOTTOM OF THE PACKAGING'S SEAL ( BY BOTTOM OF PACKAGING HE MEANS THE EYELET END OF THE CATHETER). THE POINT OF THE CATHETER WAS EXPOSED OUT OF THE PACKAGING LIKE THE BOTTOM DID NOT SEAL CORRECTLY OR THE CATHETER WAS DROPPED DOWN IN THE PACKAGING TOO FAR DOWN BEFORE IT WAS SEALED HE SAID. IT DID NOT LOOK LIKE IT WAS TORN IN ANY WAY. THE MU BOX WAS NOT DAMAGED EITHER. NO HARM WAS REPORTED. NO PHOTO AVAILABLE, PRODUCT DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402909 ↗
• MalfunctionFeb 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402903 ↗