Porges Coloplast ACP205Recalls & reported problems
Coloplast A/S · Ureteric catheter for guidewire 0.038” (0.97 mm) / Flush / Straight open tip without side eye / metal stylet / flush / radiopaque / CH FR 4.8 · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040323571), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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
- Difficult to Open or Remove Packaging Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
ACCORDING TO THE AVAILABLE INFORMATION, THE PACKAGE WAS UNABLE TO BE OPENED WITHOUT COMPROMISING STERILITY. THE PHYSICIAN OPENED A NEW ONE TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21126429 ↗
Other CATHETER, URETERAL, GASTRO-UROLOGY devices
- MEDLINE DYND13508Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall2 reports
- MEDLINE DYND13514Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall1 report
- MEDLINE DYND13510Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall1 report
- MEDLINE DYND13518Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall1 report
- MEDLINE DYND13522Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13516Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13512Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13616Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 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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