GENTLECATH GLIDE 421566Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 30768455143536), received between Feb 26, 2019 and Apr 1, 2026 — classified as 1 injury, 80 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (36 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Sharp Edges

  END USER REPORTS "SOME OF THE GC GLIDES INCLUDED IN THE SAMPLE PACK FELT PARTICULARLY UNCOMFORTABLE, "STATING THERE WAS A SCRATCHING/PINCHING SENSATION 6 TO 8 INCHES INTO INSERTION OF CATHETER" HE SAID IT FELT LIKE AROUND THE EYELETS THERE WAS A "HANGNAIL ON THERE" WITH INSERTION. HE DID NOT FORCE THEM IN FURTHER WHEN HE FELT THIS AND REMOVED THEM. HE DID NOT EXPERIENCE ANY BLEEDING. NO HARM REPORTED. HE DID NOT EXAMINE THE CATHETERS AFTER REMOVAL TO SEE OR FEEL WITH HIS HAND IF THERE WERE ANY DEFORMITIES ON THE EYELETS OR ON THE CATHETER AS HE FELT WITH INSERTION. HE SAID HE HAS VERY CALLOUSED HANDS AND LIKELY WOULDN'T HAVE BEEN ABLE TO FEEL ANY SUBTLE DEFECTS ANYWAYS. HE DISCARDED THEM. HE WAS ALSO PREPPING THEM CORRECTLY AS WELL PRIOR TO USE." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755387 ↗
• MalfunctionApr 1, 2026Sharp Edges

  END USER REPORTS "SOME OF THE GC GLIDES INCLUDED IN THE SAMPLE PACK FELT PARTICULARLY UNCOMFORTABLE, "STATING THERE WAS A SCRATCHING/PINCHING SENSATION 6 TO 8 INCHES INTO INSERTION OF CATHETER" HE SAID IT FELT LIKE AROUND THE EYELETS THERE WAS A "HANGNAIL ON THERE" WITH INSERTION. HE DID NOT FORCE THEM IN FURTHER WHEN HE FELT THIS AND REMOVED THEM. HE DID NOT EXPERIENCE ANY BLEEDING. NO HARM REPORTED. HE DID NOT EXAMINE THE CATHETERS AFTER REMOVAL TO SEE OR FEEL WITH HIS HAND IF THERE WERE ANY DEFORMITIES ON THE EYELETS OR ON THE CATHETER AS HE FELT WITH INSERTION. HE SAID HE HAS VERY CALLOUSED HANDS AND LIKELY WOULDN'T HAVE BEEN ABLE TO FEEL ANY SUBTLE DEFECTS ANYWAYS. HE DISCARDED THEM. HE WAS ALSO PREPPING THEM CORRECTLY AS WELL PRIOR TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753133 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277728 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277727 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277726 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277725 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277724 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277722 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277721 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277720 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277719 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277718 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277717 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277715 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277714 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277713 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277712 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277711 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277710 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277709 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277708 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277707 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277705 ↗
• MalfunctionFeb 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED UPON OPENING THE PACKAGES, "DARK REDDISH STAINS WERE FOUND ON THE TAPERED TIP OF THE CATHETER." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277132 ↗
• MalfunctionSep 17, 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 23072041 ↗