GENTLECATH NELATON 501004Recalls & reported problems
Convatec, Purchasing Department · Gentlecath™ Uncoated Intermittent Urinary Catheter, Straight Tip, Male - Fr/Ch14, 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 straight-tip intermittent urinary catheter is a single-use male catheter for draining the bladder. Most of the 53 reports describe the catheter having sharp edges that scraped or injured tissue during use, along with some handling issues, one twisted or bent material, and four reports of urinary tract infection; 4 injuries and no deaths were reported. No recalls name this device. Reports fell sharply in the past 12 months, with none filed since the previous 12-month period's 48.
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
- 53
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00768455145478), received between Mar 17, 2022 and Dec 13, 2024 — classified as 4 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (49 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
- Sharp Edges49
- Adverse Event Without Identified Device or Use Problem3
- Device Handling Problem2
- Material Twisted/Bent1
Patient problems
- Unspecified Tissue Injury48
- Urinary Tract Infection4
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20921875 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20921350 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20921108 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920960 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920956 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920849 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920823 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920812 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920690 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920646 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920608 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920606 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920527 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920522 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920521 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920466 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920399 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920382 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920257 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920235 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920221 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920203 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920102 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20920069 ↗MalfunctionDec 12, 2024Sharp Edges; Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20919895 ↗
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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