Porges Coloplast AB6120Recalls & reported problems

Coloplast A/S · X-FLOW® Prostatectomy catheter Couvelaire tip 3-way 30-50 ml 100% silicone CH FR 20 · 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: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03600040143711), received between Feb 14, 2020 and May 16, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 Vessel6
Device Contaminated During Manufacture or Shipping1
Device Contamination with Chemical or Other Material1
Fluid/Blood Leak1
Fracture1

Patient problems

No Clinical Signs, Symptoms or Conditions4
Discomfort2
No Known Impact Or Consequence To Patient2
Hematuria1

Recent adverse event reports

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

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 19335144 ↗
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 19335134 ↗
InjuryDec 28, 2023Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION A QUADRIPLEGIC PATIENT WAS SURVEYED REGARDING CATHETER CHANGES. ON 26/11 THE CATHETER WAS CHANGED. SINCE THAT CHANGE HEMORRHAGE ON AFFECTED ARTERIOLES, HYPOTENSION PLUS DEGLOBULATION, AND BLADDER LAVAGE WAS OBSERVED. ON 29/11 AT 9A.M., A CHANGE OF THE VESICAL LAVAGE BAG RESULTED IN THE LAVAGE LINE SPONTANEOUSLY RUPTURING, PREVENTING INSERTION OF TUBING AND NECESSITATING INSERTION OF A NEW 3-WAY INDWELLING CATHETER. THE PATIENT EXPERIENCED REACTIVATION OF HEMATURIA. THE CATHETER BECOMES REGULARLY BLOCKED, DEGLOBULATION AND HYPOTENSION NECESSITATE TRANSFUSION OF 2 UNITS OF PGR AND TRANSFER OF THE PATIENT TO INTENSIVE CARE WITH PARAMEDICS AT THE PATIENT¿S BEDSIDE FOR 3 HOURS.
Patient problems: Hematuria
MAUDE report 18409484 ↗
MalfunctionMay 16, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO CONTAMINATION. THERE WAS A MATERIAL THAT LOOKED LIKE A THREAD IN THE PACKAGING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16936819 ↗
MalfunctionDec 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ACCORDING TO THE AVAILABLE INFORMATION, THE NURSE DISCOVERED A HAIR IN THE PACKAGE BEFORE IT WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13003215 ↗
MalfunctionApr 8, 2021Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, A BALLOON BURST OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11637702 ↗
MalfunctionApr 2, 2021Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, A BALLOON BURST AND WATER LEAKAGE OCCURRED. IT WAS NOTED THAT THIS OCCURRED FIVE TIMES WITH THIS CATALOG NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11608457 ↗
MalfunctionFeb 14, 2020Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST WHEN CUFFING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9713885 ↗
MalfunctionFeb 14, 2020Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON BURST WHEN CUFFING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9713869 ↗

Device details

UDI-DI	`03600040143711`
Brand	Porges Coloplast
Model	AB6120
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.

Other CATHETER, RETENTION TYPE, BALLOON devices

Bardex® All-Silicone Foley Catheter 165816
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
512 reports
Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
476 reports
Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
1 death383 reports
Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
234 reports
Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216M
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
167 reports
Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
153 reports
Bardex® All-Silicone Foley Catheter 165812
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
151 reports
SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216
C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON
2 recalls46 reports

All CATHETER, RETENTION TYPE, BALLOON devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page