Porges Coloplast AB6318Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter Dufour tip 3-way 30-50 ml 100% silicone CH FR 18 · Class 2
All models of Porges Coloplast (79)
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.
Quick summary
This Coloplast X-FLOW silicone balloon catheter is used to drain the bladder after surgery. Most of the 45 reports describe the balloon bursting, tearing or breaking, sometimes while being filled or while the catheter was already in place; 6 reports involved injuries and none involved deaths. There is 1 open recall, started in December 2024, over a possible sterility issue traced to Coloplast's packaging.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 03600040144183), received between Sep 7, 2018 and Apr 9, 2026 — classified as 6 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (20 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
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 Vessel20
- Material Rupture17
- Break2
- Off-Label Use2
- Appropriate Device Problem Term/Code Not Available1
- Component Misassembled1
- Contamination /Decontamination Problem1
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient6
- Insufficient Information4
- No Information4
- Hematuria2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blood Loss1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Burst Container or Vessel; Off-Label Use
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS ADMITTED FOR INDUCTION OF LABOR. WHEN FOLEY CATHETER INSERTED THROUGH CERVIX, 45MLS WATER PUT INTO BALLOON THEN IT THEN BURST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835330 ↗MalfunctionSep 18, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE END USED TO CONNECT TO THE IRRIGATION BAG BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084755 ↗MalfunctionJan 23, 2025Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, ON (B)(6), A BLADDER CATHETER WAS INSERTED AT THE END OF THE DAY. THE MORNING OF (B)(6), DURING THE NURSE'S ROUNDS, THE NURSE NOTICED URINE IN THE PATIENT'S BED. SHE FOUND THE CATHETER EXTERIORIZED AND THE BALLOON RUPTURED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS WAS AN ISOLATED INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218671 ↗MalfunctionApr 22, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON HAD TORN. PATIENT WAS RE-CATHETERIZED WITH SLIGHT HEMATURIA.
Patient problems: Hematuria; Pain
MAUDE report 19154594 ↗MalfunctionMar 14, 2024Burst Container or Vessel; Off-Label Use; Burst Container or Vessel; Off-Label Use
ACCORDING TO THE AVAILABLE INFORMATION FOLEY CATHETER WAS INSERTED AND BALLOON WAS FILLED WITH 50MLS OF WATER. BEFORE COMPLETING, THE BALLOON BURST. FOLEY WAS REMOVED AND A NEW BALLOON WAS INSERTED.
Patient problems: Discomfort
MAUDE report 18906298 ↗MalfunctionMar 12, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO ADDITIONAL AVAILABLE INFORMATION, THE BALLOON WAS TESTED BEFORE INSERTION AND THE CATHETERIZATION ROUTE WAS URETHRAL. A SALINE SOLUTION WAS USED AS THE INFLATION FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18889761 ↗MalfunctionMar 12, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO ADDITIONAL AVAILABLE INFORMATION, THE BALLOON WAS TESTED BEFORE INSERTION AND THE CATHETERIZATION ROUTE WAS URETHRAL. A SALINE SOLUTION WAS USED AS THE INFLATION FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18889727 ↗MalfunctionMar 4, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION PRIOR TO INSERTION, THE BALLOON WAS PIERCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18829751 ↗MalfunctionOct 28, 2023Component Misassembled; Wrong Label; Component Misassembled; Wrong Label
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS LABELED INCORRECTLY. A DIFFERENT SIZE OF PRODUCT WAS IN THE BOX AND DID NOT MATCH THE OUTER LABEL. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18026654 ↗MalfunctionOct 12, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON CRACK. THE PATIENT NEEDED TO BE CATHETERIZED AGAIN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 17917561 ↗MalfunctionOct 12, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON CRACK. THE PATIENT NEEDED TO BE CATHETERIZED AGAIN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 17917559 ↗MalfunctionAug 15, 2023Inflation Problem; Failure to Deflate; Unintended Deflation; Inflation Problem; Failure to Deflate; Unintended Deflation
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO DIFFICULT INFLATION. THE DEVICE WAS DIFFICULT TO INFLATE AND IMPOSSIBLE TO DEFLATE. THE DEVICE EVENTUALLY SELF-DEFLATED. THE BALLOON WAS INTACT AFTER DEVICE REMOVAL. IT IS SUSPECTED THAT THE PROBLEM WAS WITH THE VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17549895 ↗MalfunctionJun 5, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056816 ↗MalfunctionJun 5, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056814 ↗MalfunctionJun 5, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056784 ↗MalfunctionJun 5, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056782 ↗MalfunctionMay 18, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. THIS HAPPENED TO FIVE DEVICES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16956182 ↗MalfunctionMay 17, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16943764 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16943710 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16943621 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16943613 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16942526 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16939038 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16939028 ↗MalfunctionMay 16, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BURST. THE BALLOON BURST AFTER BEING INFLATED WITH LESS THAN 50 ML OF STERILE WATER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16938971 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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 · 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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