GENTLECATH NELATON 501003Recalls & reported problems
Convatec, Purchasing Department · Gentlecath™ Uncoated Intermittent Urinary Catheter, Straight Tip, Male - Fr/Ch12, 16" · Class 2
All models of GENTLECATH NELATON (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Convatec Gentlecath urinary catheter has 129 adverse event reports on record, with no deaths and 1 injury. The reports mostly describe packaging that is hard to peel open, with tears or sharp holes, and some mention sharp edges on the catheter. Most say no clinical signs were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 129
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00768455145461), received between Aug 19, 2021 and Mar 2, 2026 — classified as 1 injury, 128 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (100 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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem100
- Sharp Edges27
- Tear, Rip or Hole in Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions122
- Pain7
- Bruise/Contusion1
- Urinary Tract Infection1
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Tear, Rip or Hole in Device Packaging
END USER REPORTS "SOME SEEM MORE DIFFICULT TO PEEL BACK THAN OTHERS. HE DOES NOT HAVE ANY LOT INFO AS SAID IT HAPPENS SPORADICALLY. HE SAID SOME JUST SEEM MORE DIFFICULT TO PEEL BACK WHICH IS A NUISANCE TO HIM ESPECIALLY AT NIGHT WHEN HE CATHS. HE NOTES SOMETIMES BECAUSE IT IS SO DIFFICULTY TO PEEL BACK SOMETIMES THE PAPER WILL TEAR IN VARIOUS AREAS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482912 ↗MalfunctionMar 2, 2026Tear, Rip or Hole in Device Packaging
END USER REPORTS "SOME SEEM MORE DIFFICULT TO PEEL BACK THAN OTHERS. HE DOES NOT HAVE ANY LOT INFO AS SAID IT HAPPENS SPORADICALLY. HE SAID SOME JUST SEEM MORE DIFFICULT TO PEEL BACK WHICH IS A NUISANCE TO HIM ESPECIALLY AT NIGHT WHEN HE CATHS. HE NOTES SOMETIMES BECAUSE IT IS SO DIFFICULTY TO PEEL BACK SOMETIMES THE PAPER WILL TEAR IN VARIOUS AREAS." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE PACKAGING DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482741 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255986 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255985 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255984 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255943 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255942 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255941 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255897 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255896 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255895 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255894 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255893 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255884 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255883 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255879 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255878 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
END USER STATES "ABOUT ONE IN FIVE OF THEM (ONE PER STRIP OF FIVE CONNECTED CATHETERS) AND THIS MORNING TWO SO FAR IN ONE STRIP HAVE HOLES THAT ARE VERY SHARP." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255876 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255873 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255871 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255830 ↗MalfunctionSep 19, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20255816 ↗MalfunctionApr 25, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 19181124 ↗MalfunctionApr 25, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 19181038 ↗MalfunctionApr 25, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Pain
MAUDE report 19181034 ↗
Other Catheter, Urological devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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