GENTLECATH GLIDE 421569Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 30768455143567), received between Aug 9, 2023 and Feb 4, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (25 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "PACKAGING DEFECT AND TEARING". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257128 ↗
• MalfunctionFeb 4, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "PACKAGING DEFECT AND TEARING". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257120 ↗
• MalfunctionFeb 4, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "PACKAGING DEFECT AND TEARING". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257050 ↗
• MalfunctionFeb 4, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED "PACKAGING DEFECT AND TEARING". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257047 ↗
• MalfunctionApr 4, 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 21780697 ↗
• MalfunctionApr 4, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE TIP OF THE URINARY CATHETER IS CAUGHT IN THE PACKAGING. THERE WERE NO PHOTOS PROVIDED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21780688 ↗
• MalfunctionApr 4, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE TIP OF THE URINARY CATHETER IS CAUGHT IN THE PACKAGING. THERE WERE NO PHOTOS PROVIDED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21780667 ↗
• MalfunctionNov 21, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "SOME CATHETERS WERE SMASHED BECAUSE THEY WERE TRAPPED BETWEEN THE PRIMARY PACKING SEAL/WELDING'S. THE AFFECTED PRODUCTS HAD ALTERED COLOR." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745908 ↗
• MalfunctionNov 21, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "SOME CATHETERS WERE SMASHED BECAUSE THEY WERE TRAPPED BETWEEN THE PRIMARY PACKING SEAL/WELDINGS. THE AFFECTED PRODUCTS HAD ALTERED COLOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745902 ↗
• MalfunctionNov 21, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "SOME CATHETERS WERE SMASHED BECAUSE THEY WERE TRAPPED BETWEEN THE PRIMARY PACKING SEAL/WELDINGS. THE AFFECTED PRODUCTS HAD ALTERED COLOR." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745826 ↗
• MalfunctionNov 21, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "SOME CATHETERS WERE SMASHED BECAUSE THEY WERE TRAPPED BETWEEN THE PRIMARY PACKING SEAL/WELDINGS. THE AFFECTED PRODUCTS HAD ALTERED COLOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745781 ↗
• MalfunctionSep 25, 2024Sharp Edges; Sharp Edges

  END USER STATES "SHE HAS NO FEELING IN URETHRA/ BLADDER AND IS PARALYZED. SHE SAID SHE FOUND ABOUT 4 CATHETERS AFFECTED AND ONLY USED 1 WITH THE CONCERN BEFORE NOTING THE DEFECT. USING THAT ONE AFFECTED MADE HER BLEED SO SHE DID NOT USE THEM ANYMORE AND WOULD CHECK THEM PRIOR TO USE. SHE SAID IT WAS LIKE THE END OF THE CATHETER WAS PRESSED INTO THE SIDE BY THE SEALS OF THE PACKAGING MAKING THE CATHETER COMPRESSED NEAR TIP AND SHARP. SHE FIRST SAID THESE AFFECTED WERE HARD TO PULL OUT PRIOR TO USE AND SHE USED THE FIRST ONE LIKE THIS AS SHE DIDN'T LOOK AT IT PRIOR AND IT CAUSED HER TO BLEED, SHE SAID OFF AND ON FOR WEEKS BEFORE FINALLY RESOLVING. SHE IS ON BLOOD THINNERS SO SHE SAID THIS MADE THE BLEEDING WORSE. SHE SAID IN THAT ORDER FROM MULTIPLE BOXES SHE FOUND ANOTHER 3 CATHETERS THAT WERE LIKE THIS AS SHE COULD TELL THEY WERE STUCK "OFF TO THE SIDE, STUCK WHERE THEY WERE PRESSED TOGETHER" AND BY THAT SHE MEANT THE CATHETER PACKAGING SEALS ON SIDES NEAR TIP. SHE DID NOT USE THEM AND DISCARDED THEM."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20304085 ↗
• MalfunctionSep 25, 2024Sharp Edges; Sharp Edges

  END USER STATES "SHE HAS NO FEELING IN URETHRA/ BLADDER AND IS PARALYZED. SHE SAID SHE FOUND ABOUT 4 CATHETERS AFFECTED AND ONLY USED 1 WITH THE CONCERN BEFORE NOTING THE DEFECT. USING THAT ONE AFFECTED MADE HER BLEED SO SHE DID NOT USE THEM ANYMORE AND WOULD CHECK THEM PRIOR TO USE. SHE SAID IT WAS LIKE THE END OF THE CATHETER WAS PRESSED INTO THE SIDE BY THE SEALS OF THE PACKAGING MAKING THE CATHETER COMPRESSED NEAR TIP AND SHARP. SHE FIRST SAID THESE AFFECTED WERE HARD TO PULL OUT PRIOR TO USE AND SHE USED THE FIRST ONE LIKE THIS AS SHE DIDN'T LOOK AT IT PRIOR AND IT CAUSED HER TO BLEED, SHE SAID OFF AND ON FOR WEEKS BEFORE FINALLY RESOLVING. SHE IS ON BLOOD THINNERS SO SHE SAID THIS MADE THE BLEEDING WORSE. SHE SAID IN THAT ORDER FROM MULTIPLE BOXES SHE FOUND ANOTHER 3 CATHETERS THAT WERE LIKE THIS AS SHE COULD TELL THEY WERE STUCK "OFF TO THE SIDE, STUCK WHERE THEY WERE PRESSED TOGETHER" AND BY THAT SHE MEANT THE CATHETER PACKAGING SEALS ON SIDES NEAR TIP. SHE DID NOT USE THEM AND DISCARDED THEM." THIS EMDR COVERS THE UNKNOWN LOT NUMBERS ASSOCIATED WITH THE DEFECTIVE CATHETERS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20303966 ↗
• MalfunctionFeb 7, 2024Unsealed 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 18662685 ↗
• MalfunctionDec 29, 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 18416866 ↗
• MalfunctionDec 28, 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 18408982 ↗
• MalfunctionDec 28, 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 18408978 ↗
• MalfunctionDec 28, 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 18408920 ↗
• MalfunctionDec 28, 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 18408918 ↗
• MalfunctionDec 28, 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 18408917 ↗
• MalfunctionDec 28, 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 18408916 ↗
• MalfunctionDec 28, 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 18408915 ↗
• MalfunctionDec 28, 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 18408914 ↗
• MalfunctionDec 28, 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 18408913 ↗
• MalfunctionNov 21, 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 18185034 ↗