Coloplast ACP405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040966624), received between Apr 9, 2025 and Apr 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Sharp Edges” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2025Sharp Edges; Sharp Edges

  ACCORDING TO THE AVAILABLE INFORMATION, THE GUIDE WIRE IN THE URETERAL STENT WAS INCORRECTLY SHAPED. TYPICALLY, THE END IS SHAPED INTO A LOOP. IN THIS CASE, THE END IS POINTED AND SHARP-EDGED AND THE DOCTOR PRICKED HIS RIGHT THUMB WHEN PULLING OUT THE CATHETER. THE DOCTOR'S INJURY WAS REPAIRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21805066 ↗