Porges Coloplast AB6324Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter Dufour tip 3-way 30-50 ml 100% silicone CH FR 24 · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03600040144572), received between Aug 26, 2015 and Nov 7, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Dec 2, 2024Open, Classified
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Z-0845-2025 · Root cause: Packaging · FDA record ↗
Most reported problems
Device problems
- Burst Container or Vessel2
- Device Contaminated During Manufacture or Shipping2
- Material Rupture2
- Device Contamination with Chemical or Other Material1
- Device Packaging Compromised1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Pain2
- Insufficient Information1
- No Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ACCORDING TO THE AVAILABLE INFORMATION, A PIECE OF HAIR WAS IN THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630057 ↗MalfunctionSep 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION, HAIR WAS FOUND IN THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140034 ↗MalfunctionJun 21, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON HAD BEEN PIERCED AND THE CATHETER FELL OFF BY ITSELF. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580222 ↗MalfunctionApr 19, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION DIRT WAS FOUND INSIDE THE PACKAGING. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19143034 ↗MalfunctionFeb 1, 2024Burst Container or Vessel; Burst Container or Vessel
ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST/RUPTURED. NO SERIOUS CONSEQUENCES FOR THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18623610 ↗MalfunctionJul 27, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO BALLOON BURST. THE PATIENT REPORTED PAIN, THE DEVICE WAS FOUND IN THE BED WITH A BURST BALLOON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 17410865 ↗MalfunctionJul 27, 2023Material Rupture; Material Rupture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO BALLOON BURST. THE PATIENT REPORTED PAIN, THE DEVICE WAS FOUND IN THE BED WITH A BURST BALLOON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 17409923 ↗MalfunctionAug 26, 2015Device Packaging Compromised
ACCORDING TO THE INFORMATION RECEIVED, DIRTS AND/OR HAIRS ARE FOUND AT AROUND THE TIP OF THE CATHETERS.
Patient problems: No Information
MAUDE report 5033358 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.