Porges Coloplast AB6018Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter straight tip 3 way 30-50ml 100% silicone CH FR 18 · 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 03600040143100), received between Jul 11, 2017 and Oct 27, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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.
Most reported problems
Device problems
- Burst Container or Vessel1
- Split1
Patient problems
- Localized Skin Lesion1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2021Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION, A LEAK OCCURRED ON A VESICAL 3-WAY CATHETER, DURING THE REPLACEMENT OF THE CATHETER, THE BALLOON BURST THREE TIMES. IT WAS UNCLEAR IF THREE CATHETERS HAD BALLOON BURSTS, OR IF A SINGLE BALLOON BURST IN THREE PLACES. THE PATIENT UNDERWENT INVASIVE INTERVENTION, AND SOME LESION OF CUTANEOUS STATE FOLLOWING CONTACT WITH URINE.
Patient problems: Localized Skin Lesion
MAUDE report 12705388 ↗MalfunctionJul 11, 2017Split
ACCORDING TO THE AVAILABLE INFORMATION, IT IS SEVERAL TIMES THAT OPERATORS COMPLAIN ON CATHETERS FOLEY AA61 OR CATHETERS AB60: THEY SAY THAT THE ROD SPLITS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6702962 ↗
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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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