Porges Coloplast AB6118Recalls & reported problems

Coloplast A/S · X-FLOW® Prostatectomy catheter Couvelaire tip 3-way 30-50 ml 100% silicone CH FR 18 · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 9
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03600040143629), received between Feb 6, 2019 and Jan 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Dec 2, 2024Class IIOpen, Classified
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Z-0845-2025 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Device problems

Burst Container or Vessel8
Material Rupture2
Device Contaminated During Manufacture or Shipping1

Patient problems

Discomfort2
Insufficient Information2
No Clinical Signs, Symptoms or Conditions2
Pain2
Urinary Retention2
No Information1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 9, 2025Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, WHOLE INFLATING THE BALLOON WITH AIR, IT BURST AND THE CATHETER FELL OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113259 ↗
MalfunctionMay 16, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION WHEN CHECKING THE CORRECT POSITIONING OF THE BALLOON, THE BALLOON WAS INFLATED TO 50CC WHEN THE BALLOON BURST. PATIENT EXPERIENCED PAIN AND NON-IRRIGATED HEMATURIA.
Patient problems: Discomfort
MAUDE report 19334969 ↗
MalfunctionMay 16, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION WHEN CHECKING THE CORRECT POSITIONING OF THE BALLOON, THE BALLOON WAS INFLATED TO 50CC WHEN THE BALLOON BURST. PATIENT EXPERIENCED PAIN AND NON-IRRIGATED HEMATURIA.
Patient problems: Discomfort
MAUDE report 19334928 ↗
MalfunctionApr 18, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST AND FELL OUT. NO HARM TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19135354 ↗
MalfunctionNov 14, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture
ACCORDING TO THE AVAILABLE INFORMATION AFTER PLACEMENT OF THE CATHETER, AFTER SURGERY, THE BALLOON RUPTURED. A SECOND CATHETER WAS PLACED; HOWEVER, THIS BALLOON ALSO RUPTURED. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF EACH CATHETER, AND ALSO EXPERIENCED URINARY RETENTION.
Patient problems: Pain; Urinary Retention
MAUDE report 18132482 ↗
MalfunctionNov 14, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture
ACCORDING TO THE AVAILABLE INFORMATION AFTER PLACEMENT OF THE CATHETER, AFTER SURGERY, THE BALLOON RUPTURED. A SECOND CATHETER WAS PLACED; HOWEVER, THIS BALLOON ALSO RUPTURED. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF EACH CATHETER, AND ALSO EXPERIENCED URINARY RETENTION.
Patient problems: Pain; Urinary Retention
MAUDE report 18132438 ↗
MalfunctionNov 13, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS OBSERVED TO HAVE RED FOREIGN MATERIALS ON IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18121649 ↗
MalfunctionFeb 25, 2023Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A BALLOON BURST. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 16440922 ↗
MalfunctionFeb 6, 2019Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, CATHETER FELL OFF AFTER 3 DAYS INDWELLING DUE TO BALLOON BURSTS. DR. HAS REPLACED WITH NEW PRODUCT IMMEDIATELY, NO CLINICAL CONSEQUENCES REPORTED, ALSO CONFIRMED NO RESIDUE OR PARTICLE REMAINS IN PATIENT'S BLADDER.
Patient problems: No Information
MAUDE report 8311082 ↗

Device details

UDI-DI	`03600040143629`
Brand	Porges Coloplast
Model	AB6118
Company	Coloplast A/S
Product code	EZL · CATHETER, RETENTION TYPE, BALLOON
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	Aug 30, 2024

Device type (GMDN): Indwelling urethral drainage balloon catheter, non-antimicrobial

A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. 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 · each recall links to the FDA recall notice
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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