GENTLECATH GLIDE 421568Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30768455143550), received between Jan 8, 2024 and Nov 19, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS UNKNOWN QTY, UNKNOWN MUS, UNKNOWN LOTS OVER THE LAST 1.5 YRS - INITIALLY WHEN FIRST USING WOULD GET UTIS AND HE THINKS IT WAS A CONCERN WITH PAPER INTEGRITY ON THE CATHETER PACKAGING. HE SAID HE NEEDED TREATMENT OF ANTIBIOTICS FOR THOSE AND THEN HIS MD PLACED HIM ON LOW DOSE MACROBID TO AVOID INFECTIONS SO WHILE HE HAS STILL NOTICED THIS ISSUE OFF AN ON THROUGHOUT THE 1.5 YRS HE HAS USED THEM HE HASN'T GOTTEN ANYMORE UTIS SINCE TAKING LOW DOSE PROPHYLACTIC MACROBID DAILY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 20728338 ↗
• MalfunctionNov 19, 2024Sharp Edges; Sharp Edges

  END USER REPORTED HE HAS BEEN CATHING SINCE 2012 FOLLOWING DIAGNOSIS OF BPH AND A TURP SURGERY. HE REPORTED HE PLACED ONE CATHETER AND IT HURT MORE THAN NORMAL AND HE TOOK IT OUT, RAN HIS FINGERS DOWN IT AND SAID WHEN HE RAN HIS FINGERS BY THE TIP, BY THE EYELETS AREA "IT FELT REALLY PRETTY ROUGH" LIKE THEY WEREN'T POLISHED WELL. HE SAID HE PREPPED IT PROPERLY AND SAID AS HE JUST STARTED EXAMINING THE CATHETERS IN THE BOX AND HE ESTIMATES ABOUT HALF CATHETERS IN THE BOX WERE LIKE THAT. HE SAID THEY FELT ROUGH BY EYELETS PRIOR TO BURSTING WATER SACHET AND AFTER. HE DISCARDED THEM.

  Patient problems: Pain

  MAUDE report 20727954 ↗
• MalfunctionJan 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DISTRIBUTOR REPORTS "PAPER ON PACKAGING TEARING UNEVENLY WHEN OPENING. HE COULD NOT QUANTITY HOW MANY AS HE SAID HE OPENED A FEW FROM MULTIPLE BOXES OF ALL OF THE LOTS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581123 ↗
• MalfunctionJan 25, 2024Tear, 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 18581121 ↗
• MalfunctionJan 25, 2024Tear, 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 18580977 ↗
• MalfunctionJan 25, 2024Tear, 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 18580975 ↗
• MalfunctionJan 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DISTRIBUTOR REPORTS THE "PAPER ON PACKAGING TEARING UNEVENLY WHEN OPENING. HE CHECKED MULTIPLE CATHETERS FROM MULTIPLE MUS HE HAD IN HIS SUPPLY STORE OF 421569 AND NOTED EVERY SINGLE ONE HE TRIED TO OPEN HAD THE SAME ISSUE. HE NOTICED AS HE OPENED THEM BY PEELING THE TABS APART, THE PAPER WAS RIPPING ANYWHERE FROM 1/4 OF THE WAY TO 1/2 DOWN." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580874 ↗
• MalfunctionJan 25, 2024Tear, 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 18580872 ↗
• MalfunctionJan 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DISTRIBUTOR STATES THAT A CONSUMER NOTIFIED HIM OF A COMPLAINT OF HAVING DIFFICULTY OPENING THESE CATHETERS. COMPLAINT WAS THEM TEARING UNEVENLY WHEN PEELING OPEN. THE "PAPER WAS RIPPING ANYWHERE FROM 1/4 OF THE WAY TO 1/2 DOWN" WHEN TRYING TO PEEL OPEN. DISTRIBUTOR SAID HE "CHECKED MORE OF THE STOCK HE HAD OF THIS PRODUCT AND OPENED MULTIPLE AND NOTICED MULTIPLE FROM MULTIPLE BOXES AND THEY WERE ALL HAVING THIS CONCERN. HE SAID HE HAS ALREADY REPLACED THE CONSUMER'S CATHETERS WITH A CATHETER IN DIFFERENT PACKAGING AS HE HAD LIMITED DEXTERITY, HANDICAPPED AND NEEDED IT TO OPEN COMPLETELY WITHOUT IT TEARING. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579212 ↗
• MalfunctionJan 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DISTRIBUTOR STATES THAT A CONSUMER NOTIFIED HIM OF A COMPLAINT OF HAVING DIFFICULTY OPENING THESE CATHETERS. COMPLAINT WAS THEM TEARING UNEVENLY WHEN PEELING OPEN. THE "PAPER WAS RIPPING ANYWHERE FROM 1/4 OF THE WAY TO 1/2 DOWN" WHEN TRYING TO PEEL OPEN. DISTRIBUTOR SAID HE "CHECKED MORE OF THE STOCK HE HAD OF THIS PRODUCT AND OPENED MULTIPLE AND NOTICED MULTIPLE FROM MULTIPLE BOXES AND THEY WERE ALL HAVING THIS CONCERN. HE SAID HE HAS ALREADY REPLACED THE CONSUMER'S CATHETERS WITH A CATHETER IN DIFFERENT PACKAGING AS HE HAD LIMITED DEXTERITY, HANDICAPPED AND NEEDED IT TO OPEN COMPLETELY WITHOUT IT TEARING. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT. THIS EMDR COVERS THE UNKNOWN MARKET UNITS/LOT NUMBERS ASSOCIATED WITH THE DEFECTIVE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579211 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 18477114 ↗
• MalfunctionJan 8, 2024Tear, 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 18463655 ↗