Porges Coloplast AB6C20Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter straight tip 3-way 15-30 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.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03600040146354), received between Oct 11, 2022 and Nov 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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 Vessel1
- Contamination1
Patient problems
- Discomfort1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, DOUBLE CURRENT BLADDER CATHETER INSERTION WITHOUT DIFFICULTY AND THE BALLOON INFLATED TO 15CC OF WATER. TWO WASHING POCKETS GO THROUGH EASILY BUT ON THE THIRD THE PATIENT IS IN PAIN. THE LIQUID NO LONGER FLOWS INTO THE COLLECTION BAG AND IT IS ATTEMPTED TO UNCLOG THINKING IT COULD BE A BLOOD CLOT IN THE BLADDER. IT WAS UNABLE TO REMOVE THE LIQUID WITH A SYRINGE. THE CATHETER WAS REPOSITIONED AND THE LIQUID LEAVES. THE CATHETER CAME OUT WITH THE BALLOON EMPTY. THE CATHETER WAS TESTED WHICH LEAKED VERY SLOWLY AND WAS SPLIT. A NEW CATHETER WAS INSERTED SUCCESSFULLY.
Patient problems: Discomfort; Pain
MAUDE report 20592238 ↗MalfunctionOct 11, 2022Contamination; Contamination
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO CONTAMINATION. A HAIR WAS WRAPPED AROUND THE CATHETER PORT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15583441 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
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- 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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