Porges Coloplast AB6218Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter Delinotte tip 3-way 30-50 ml 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 03600040143988), received between Jan 30, 2018 and Sep 5, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Dislodged or Dislocated1
- Material Rupture1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE HAD A BALLOON BURST. THE BALLOON BURST AFTER BEING INFLATED WITH 50 ML AFTER 2 L OF IRRIGATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17682227 ↗InjuryJan 30, 2018Break; Device Dislodged or Dislocated
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT TORE OFF HIS CATHETER WHEN HE WILL STOOD UP. THE CATHETER IS BROKEN INSIDE URETHRA. CLINICAL CONSEQUENCE : THE PATIENT IS TRANSFERRED TO THE OPERATING ROOM. AND OTHER CATHETER WAS BEEN IN PLACE.
Patient problems: Foreign Body In Patient; No Information
MAUDE report 7227903 ↗
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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
- 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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