GENTLECATH TIEMANN 501013Recalls & reported problems

Convatec, Purchasing Department · Gentlecath™ Uncoated Intermittent Urinary Catheter, Tiemann Tip, Male - Fr/Ch12, 16" · Class 2

All models of GENTLECATH TIEMANN (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This GentleCath Tiemann intermittent urinary catheter is a male single-use tube used to drain the bladder. The 88 reports mostly describe the funnel not lining up with the curved tip, suggesting parts were misassembled during making or shipping; there are no deaths, one injury reporting bleeding, and one mentioning a urinary tract infection. No recalls name this device. Reports fell from 82 in the earlier 12 months to 0 in the most recent 12 months.

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: 88
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00768455145522), received between Feb 10, 2023 and Jun 8, 2025 — classified as 1 injury, 87 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (87 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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Device Misassembled During Manufacturing /Shipping87
Adverse Event Without Identified Device or Use Problem1
Device Handling Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions86
Hemorrhage/Blood Loss/Bleeding1
Urinary Tract Infection1

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164627 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164626 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164625 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164624 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164623 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164622 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164621 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164620 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164619 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164618 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164617 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164616 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164615 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164614 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164613 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164612 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164611 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164610 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164609 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164608 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164607 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164606 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164605 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164604 ↗
MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164603 ↗

Device details

UDI-DI	`00768455145522`
Brand	GENTLECATH TIEMANN
Model	501013
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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