Coloplast ACP305Recalls & reported problems
Coloplast A/S · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040966266), received between Sep 29, 2025 and Sep 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2025Material Separation; Material Separation
ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS INSERTED WITHOUT DIFFICULTY AND THE CONTRAST AGENTS WERE ADMINISTERED. DURING REMOVAL, THE CATHETER BROKE IN TWO, RESULTING IN A PIECE OF THE CATHETER REMAINING IN THE URETER. FOREIGN BODY FORCEPS WERE USED TO REMOVE THE PIECE OF CATHETER STUCK IN THE URETER. THE PIECE WAS SUCCESSFULLY REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 23169345 ↗
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 DYND13515Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13614Medline Industries, Inc. · CATHETER, URETERAL, GASTRO-UROLOGY1 recall0 reports
- MEDLINE DYND13520Medline 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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