Porges Coloplast AB6420Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter Dufour tip 2-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.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040144770), received between Feb 27, 2025 and Feb 27, 2025 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2025Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD NO INDWELLING CATHETERIZATION. THE PATIENT PRESENTED A BLADDER GLOBE. HE HAD AN ENLARGED PROSTATE THAT WAS ABOUT TO BE RESECTED. THE NURSE WENT THROUGH THE NATURAL ROUTE AND WHEN CHECKING THE BALLOON, THE NURSE FOUND NO ASYMMETRY OR OTHER PHENOMENA. THE NURSE USED A LUBRICANT, THEN INFLATED THE BALLOON WITH WATER PPI. THE NURSE DID NOT NEED TO USE THE IRRIGATION WAY. THE NURSE FILLED THE BALLOON WITH ABOUT 50ML AND PLACED THE CATHETER AND A LATER TIME, WHEN THE PATIENT WAS GETTING UP, THE CATHETER FELL AND NOTICED THAT THE BALLOON WAS BROKEN / CRACKED. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT, AND ANOTHER CATHETER WAS INSERTED LATER THAT DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21485132 ↗
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- 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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