GENTLECATH TIEMANN 501014Recalls & reported problems

Convatec, Purchasing Department · Gentlecath™ Uncoated Intermittent Urinary Catheter, Tiemann Tip, Male - Fr/Ch14, 16" · Class 2

All models of GENTLECATH TIEMANN (3)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Convatec Gentlecath Tiemann urinary catheter has 109 malfunction reports, with no deaths and no injuries. Most reports describe catheters where the curved tip is not lined up with the marker on the funnel end, which one report says made use harder. No recalls name 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: 111
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00768455145539), received between Feb 8, 2022 and Sep 14, 2026 — classified as 111 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (107 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping107
Device Contaminated During Manufacture or Shipping2
Sharp Edges2

Patient problems

No Clinical Signs, Symptoms or Conditions106
Hemorrhage/Blood Loss/Bleeding5
Tissue Breakdown2

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 14, 2026Device Misassembled During Manufacturing /Shipping
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50758465 ↗
MalfunctionSep 14, 2026Device Misassembled During Manufacturing /Shipping
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50758458 ↗
MalfunctionNov 25, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED "THE END USER BOUGHT 2 BOXES OF THE PRODUCT AND HE SAYS THAT SOME CATHETERS REMAIN TO HAVE THE COUDÉ TIP NOT ALIGNED WITH THE RAISED FIN FOR THE COUDÉ ON THE FUNNEL END."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644593 ↗
MalfunctionOct 15, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THAT IN ABOUT 1/3 OF EVERY BOX, THERE ARE CATHETERS THAT HAVE THE COUDÉ FIN NOT ALIGNED WITH THE COUDÉ TIP. HE SAYS THIS ISSUE HAS BEEN ONGOING THAT HE STOPPED COUNTING. NO PHOTO AVAILABLE. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299451 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646193 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646192 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP." UNKNOWN ACTUAL QUANTITY OF AFFECTED CATHETERS AND NO LOT NUMBER PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646191 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646189 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646067 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646060 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646059 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646058 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646057 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS "THE INDICATOR LINE ON THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP. THIS MAKES THE USE OF THE COUDÉ CATHETER MORE DIFFICULT. IN ORDER TO USE THE CATHETERS, HE IS MARKING THE CATHETER ON THE FUNNEL END WITH A LINE ACTING AS THE INDICTOR LINE FOR THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646056 ↗
MalfunctionJul 1, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646055 ↗
MalfunctionFeb 20, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738007 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550857 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550856 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550838 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550837 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550836 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550834 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550833 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550832 ↗
MalfunctionJan 22, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE INDICATOR LINE ON THE FUNNEL OF THE CATHETER IS NOT ALWAYS ALIGNED WITH THE COUDÉ TIP. NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18550808 ↗

Device details

UDI-DI	`00768455145539`
Brand	GENTLECATH TIEMANN
Model	501014
Company	Convatec, Purchasing Department
Product code	KOD · Catheter, Urological
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 16, 2024

Device type (GMDN): Single-administration urethral drainage catheter

A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

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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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