Coloplast ACP606Recalls & reported problems
Coloplast A/S · Class 2
- 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 03600040967010), received between Oct 7, 2025 and Oct 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (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
- Nonstandard Device1
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.
MalfunctionOct 7, 2025Nonstandard Device; Nonstandard Device
ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER WAS FOUND DAMAGED BEFORE USE (TIP BENT AND TWISTED) IN PACKAGING. ANOTHER CATHETER WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23236160 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.