Porges Coloplast AB6320Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter Dufour tip 3-way 30-50 ml 100% silicone CH FR 20 · 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 is a Coloplast X-FLOW Dufour tip retention catheter, a three-way silicone Foley used after prostate surgery to drain the bladder. The 32 adverse event reports mostly describe the balloon bursting, tearing or fragmenting, sometimes leaving pieces in the patient, along with deflation and inflation trouble, hair found inside the sterile packaging, and pain or discomfort when the catheter came out. Six reports involved injuries and no deaths were reported. One open recall, started in December 2024, covers a possible sterility issue at the Coloplast facility traced to 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
- 32
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03600040144312), received between Feb 3, 2016 and Feb 28, 2025 — classified as 6 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (16 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 Vessel16
- Material Rupture5
- Device Contamination with Chemical or Other Material4
- Deflation Problem3
- Inflation Problem2
- Material Fragmentation2
- Microbial Contamination of Device2
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient3
- Pain3
- Discomfort2
- Fungal Infection2
- Device Embedded In Tissue or Plaque1
- Inflammation1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 28, 2025Contamination; Contamination
ACCORDING TO THE AVAILABLE INFORMATION, PRESENCE OF HAIR WAS IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21496953 ↗MalfunctionJul 17, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT WAS FOUND NOT CATHETERIZED AT MORNING DIAPER CHANGE AND THE BALLOON WAS FOUND RUPTURED. PATIENT WAS RE-CATHETERIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19766035 ↗MalfunctionJun 21, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON HAD BEEN PIERCED AND THE CATHETER FELL OFF BY ITSELF. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580254 ↗InjuryJun 14, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST AND FRAGMENTS WERE REPORTED MISSING. NO INTERVENTION WAS NEEDED AT THIS TIME AND A NEW CATHETER WAS PLACED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19537834 ↗InjuryJun 14, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST AND FRAGMENTS WERE REPORTED MISSING. NO INTERVENTION WAS NEEDED AT THIS TIME AND A NEW CATHETER WAS PLACED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19537833 ↗MalfunctionApr 17, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION WHEN REMOVING THE CATHETER, THE NURSE DISCOVERED A DEFECTIVE BALLOON. THE BALLOON HAD A HOLE IN ABOUT 3 CM IN SIZE. A NEW CATHETER WAS NOT INSERTED AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19126305 ↗MalfunctionFeb 6, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT WAS CATHETERIZED. NO CLINICAL CONSEQUENCES.
Patient problems: Discomfort; Pain
MAUDE report 18651248 ↗MalfunctionFeb 6, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST ON TWO OCCASIONS. THERE WERE NO CLINICAL CONSEQUENCES BUT PAIN AND DISCOMFORT FOR THE PATIENT.
Patient problems: Discomfort; Pain
MAUDE report 18651241 ↗MalfunctionOct 16, 2023Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE BALLOON WAS INFLATED WITH 40 ML OF EPPI. A FEW MINUTES LATER, THE NURSE NOTICED THAT THE DEVICE WAS NOT HOLDING AS THE BALLOON HAD RUPTURED. A SECOND DEVICE OF THE SAME DIAMETER WAS INSERTED WITH SLIGHTLY LESS EPPI (30-35 ML) BUT THE BALLOON RUPTURED AGAIN. A THIRD DEVICE OF THE SAME DIAMETER WITH THE SAME VOLUME OF EPPI (30-35 ML) BUT FROM A DIFFERENT BATCH TO THE SECOND WAS PLACED. THE BALLOON BURST AGAIN. FINALLY, A FOURTH DEVICE (30-35 ML OF EPPI IN THE BALLOON) WAS PLACED. AS THE PATIENT LEFT WITH THIS DEVICE AND IT WAS ASSUMED THAT THE BALLOON HAD HELD. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17946567 ↗MalfunctionSep 30, 2023Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE BALLOON WAS INFLATED WITH 40 ML OF EPPI. A FEW MINUTES LATER, THE NURSE NOTICED THAT THE DEVICE WAS NOT HOLDING AS THE BALLOON HAD RUPTURED. A SECOND DEVICE OF THE SAME DIAMETER WAS INSERTED WITH SLIGHTLY LESS EPPI (30-35 ML) BUT THE BALLOON RUPTURED AGAIN. A THIRD DEVICE OF THE SAME DIAMETER WITH THE SAME VOLUME OF EPPI (30-35 ML) BUT FROM A DIFFERENT BATCH TO THE SECOND WAS PLACED. THE BALLOON BURST AGAIN. FINALLY, A FOURTH DEVICE (30-35 ML OF EPPI IN THE BALLOON) WAS PLACED. AS THE PATIENT LEFT WITH THIS DEVICE AND IT WAS ASSUMED THAT THE BALLOON HAD HELD. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849130 ↗MalfunctionSep 30, 2023Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE BALLOON WAS INFLATED WITH 40 ML OF EPPI. A FEW MINUTES LATER, THE NURSE NOTICED THAT THE DEVICE WAS NOT HOLDING AS THE BALLOON HAD RUPTURED. A SECOND DEVICE OF THE SAME DIAMETER WAS INSERTED WITH SLIGHTLY LESS EPPI (30-35 ML) BUT THE BALLOON RUPTURED AGAIN. A THIRD DEVICE OF THE SAME DIAMETER WITH THE SAME VOLUME OF EPPI (30-35 ML) BUT FROM A DIFFERENT BATCH TO THE SECOND WAS PLACED. THE BALLOON BURST AGAIN. FINALLY, A FOURTH DEVICE (30-35 ML OF EPPI IN THE BALLOON) WAS PLACED. AS THE PATIENT LEFT WITH THIS DEVICE AND IT WAS ASSUMED THAT THE BALLOON HAD HELD. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849128 ↗MalfunctionAug 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A HAIR IN THE PACKAGING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17552616 ↗MalfunctionJun 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A HAIR. A HAIR WAS FOUND IN THE PACKAGING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17080076 ↗InjuryMay 26, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST DURING USE. THE DEVICE WAS INJECTED WITH 45ML OF WATER AND THE BALLOON BURST INTO SEVERAL PIECES, SOME OF WHICH COULD NOT BE EXTRACTED. THE PATIENT WAS PUT UNDER SURVEILLANCE THERE ARE NO CONSEQUENCES TO DATE.
Patient problems: Foreign Body In Patient
MAUDE report 17010304 ↗InjuryMay 26, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST DURING USE. THE DEVICE WAS INJECTED WITH 45ML OF WATER AND THE BALLOON BURST INTO SEVERAL PIECES, SOME OF WHICH COULD NOT BE EXTRACTED. THE PATIENT WAS PUT UNDER SURVEILLANCE THERE ARE NO CONSEQUENCES TO DATE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17010303 ↗MalfunctionFeb 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A HAIR IN THE PACKAGING. THE HAIR WAS IN DIRECT CONTACT WITH THE DEVICE, IN THE INTERNAL PACKAGING AND VISIBLE AT OPENING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16336495 ↗MalfunctionDec 14, 2022Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE BURST WHEN IT WAS INFLATED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15979372 ↗MalfunctionNov 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE A HAIR IN THE PACKAGING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15826080 ↗MalfunctionOct 31, 2022Microbial Contamination of Device; Microbial Contamination of Device
ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED A RARE FUNGAL INFECTION AFTER HAVING THE DEVICE PLACED IN THE EMERGENCY ROOM. THE FUNGAL INFECTION WAS ISOLATED IN A UEC AFTER PLACEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Fungal Infection
MAUDE report 15705392 ↗MalfunctionOct 31, 2022Microbial Contamination of Device; Microbial Contamination of Device
ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED A RARE FUNGAL INFECTION AFTER HAVING THE DEVICE PLACED IN THE EMERGENCY ROOM. THE FUNGAL INFECTION WAS ISOLATED IN A UEC AFTER PLACEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Fungal Infection
MAUDE report 15705386 ↗MalfunctionOct 3, 2022Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REMOVAL DUE TO A BALLOON SPLIT. THE PATIENT HAD THE DEVICE PLACED AFTER A PROSTATIC RESECTION AND 5 MINUTES AFTER PLACEMENT THE PATIENT EXPERIENCED HYPERALGESIA. THE NURSE NOTED THAT THE DEVICE WAS ALMOST OUT. AFTER THE DEVICE WAS REMOVED, IT WAS NOTED THE BALLOON HAD BEEN SPLIT ALONG ITS ENTIRE LENGTH. THE BALLOON WAS INFLATED WITH 40 ML OF WATER AS RECOMMENDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 15531639 ↗InjuryFeb 18, 2022Deflation Problem; Deflation Problem
ACCORDING TO AVAILABLE INFORMATION, THE BALLOON OF THIS DEVICE DEFLATED UNINTENTIONALLY. THE DEVICE WAS PLACED AFTER SURGERY AND HAD DEFLATED BEFORE THE PATIENT WAS TO RETURN HOME. THE PATIENT WAS HOSPITALIZED AN EXTRA NIGHT UNTIL NATURAL URINATION RETURNED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13563384 ↗MalfunctionOct 27, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, WATER COULD NOT BE INJECTED INTO THE BALLOON IN THE MIDDLE OF INFLATING. AFTER THAT, WATER COULD NOT BE REMOVED FROM THE BALLOON EITHER. ANOTHER PRODUCT WAS USED ALTERNATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12705910 ↗MalfunctionMay 27, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ACCORDING TO THE AVAILABLE INFORMATION, A HAIR WAS FOUND INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896600 ↗MalfunctionMay 7, 2021Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER WAS PLACED ON (B)(6) 2021 AND THE BALLOON RUPTURED THE FOLLOWING DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11790054 ↗
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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