Porges Coloplast AB6020Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter straight 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03600040143230), received between Aug 22, 2018 and Oct 31, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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
Most reported problems
Device problems
- Deflation Problem1
- Failure to Deflate1
Patient problems
- Hematuria1
- 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.
MalfunctionOct 31, 2023Failure to Deflate; Failure to Deflate
ACCORDING TO THE AVAILABLE INFORMATION DURING TESTING OF THE CATHETER OUTSIDE THE PATIENT, THE BALLOON WAS VERY HARD TO INFLATE AND IMPOSSIBLE TO DEFLATE. THE BALLOON WAS INFLATED WITH A 50ML SYRINGE AND STERILE WATER. A NEW CATHETER WAS USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18040461 ↗InjuryAug 22, 2018Deflation Problem; Deflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE BALLOON DEFLATES OR IS PIERCED ONE WEEK FOLLOWING PLACEMENT OF THE CATHETER. NEED TO CHANGE THE CATHETER OF THE PATIENT MORE OFTEN THAN NORMAL. THIS OCCURED SEVERAL TIMES. CONSEQUENCE: HEMATURIA, PAINS.
Patient problems: Hematuria; Pain
MAUDE report 7804411 ↗
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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
- 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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