Coloplast AC5910Recalls & reported problems

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 03600040964255), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Degraded1

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.

MalfunctionNov 19, 2024Degraded; Degraded
ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER TIP HAS A DEFECT WITH A HIGH RISK THAT THE TIP COULD BREAK OFF IN THE PATIENT. A NEW CATHETER WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20725750 ↗

Device details

UDI-DI	`03600040964255`
Brand	Coloplast
Model	AC5910
Company	Coloplast A/S
Product code	EYB · CATHETER, URETERAL, GASTRO-UROLOGY
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 22, 2024

Device type (GMDN): Ureteral catheter

A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.