Porges Coloplast AB6024Recalls & reported problems
Coloplast A/S · X-FLOW® Prostatectomy catheter straight tip 3-way 30-50 ml 100% silicone CH FR 24 · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03600040143490), received between Oct 11, 2023 and Oct 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (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. 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
- Unintended Deflation2
Patient problems
- Hematuria2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2023Unintended Deflation; Unintended Deflation
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE DEFLATED AFTER PLACEMENT. THE DEVICE WAS TESTED BEFORE PLACEMENT AND WAS FOUND IN THE PATIENT'S BED 5 MINUTES AFTER PLACEMENT. THE BALLOON DEFLATED SPONTANEOUSLY. HEMATURIA LINKED TO MULTIPLE INSERTIONS OF THE DEVICE.
Patient problems: Hematuria
MAUDE report 17917489 ↗MalfunctionOct 11, 2023Unintended Deflation; Unintended Deflation
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE DEFLATED AFTER PLACEMENT. THE DEVICE WAS TESTED BEFORE PLACEMENT AND WAS FOUND IN THE PATIENT'S BED 15 MINUTES AFTER PLACEMENT. THE BALLOON DEFLATED SPONTANEOUSLY. HEMATURIA LINKED TO MULTIPLE INSERTIONS OF THE DEVICE.
Patient problems: Hematuria
MAUDE report 17917454 ↗
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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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