GENTLECATH GLIDE 421565Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30768455143529), received between Jun 17, 2020 and Sep 24, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 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 20296426 ↗
• MalfunctionSep 24, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS "PAPER HAS TORN AT THE BACKSIDE WHEN IT COMES TO BE ACTIVATED". THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295762 ↗
• MalfunctionSep 24, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  END USER REPORTS "PAPER HAS TORN AT THE BACKSIDE WHEN IT COMES TO BE ACTIVATED". THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295722 ↗
• MalfunctionSep 24, 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 20295570 ↗
• MalfunctionSep 24, 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 20294923 ↗
• MalfunctionOct 16, 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 17938574 ↗
• MalfunctionJun 30, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED "THE TIP OF THE CATHETER IS CRIMPED TO THE PACKAGE." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237590 ↗
• MalfunctionApr 11, 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 16713201 ↗
• MalfunctionJun 17, 2020Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation; Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164095 ↗
• MalfunctionJun 17, 2020Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation; Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164091 ↗
• MalfunctionJun 17, 2020Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation; Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED BY THE PRODUCT END USER THAT "HE FOUND THE TIP OF THE CATHETER GET DAMAGED BY GETTING FLAT". UPON RECEIVING FOLLOW UP INFORMATION FROM THE REPORTER THE PRODUCT AS NOTED TO BE "CAUGHT IN WELDING OF THE PACKAGE". THE END USER DID NOT USE THE PRODUCT, NO HARM REPORTED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE OF THE TIPS BEING FLAT WERE SUBMITTED BY THE COMPLAINANT. NO PHOTOGRAPH DEPICTING THE PRODUCT CAUGHT IN WELD WAS SUBMITTED BY COMPLAINANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164086 ↗
• MalfunctionJun 17, 2020Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation; Delivered as Unsterile Product; Device Damaged Prior to Use; Material Deformation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164084 ↗
• MalfunctionJun 17, 2020Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163734 ↗