Ultrathane G30401Recalls & reported problems

Cook Incorporated · Ultrathane Suprapubic Catheter Set · Class 2

Data updated Oct 16, 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 00827002304017), received between Feb 15, 2017 and Feb 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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

Device problems

Leak/Splash1
Torn Material1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

InjuryFeb 15, 2017Leak/Splash; Torn Material; Leak/Splash; Torn Material
AS REPORTED TO CUSTOMER RELATIONS, "THE PATIENT HAD THE CATHETER PUT IN AROUND 12 NOON. WHILE IN RECOVERY AT THE HOSPITAL, THEY HAD TO BRING HER BACK TO THE O.R. BECAUSE THE CATHETER WAS LEAKING. THE CATHETER WAS REPLACED WITH A NEW G30401-J-USCS-120025." LEAKING PART WAS THE WHITE PART OF THE TUBE AT THE END WHERE THE ARM LOCKS DOWN. IT IS BELIEVED THAT IT WAS CUT UPON REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6331382 ↗

Device details

UDI-DI	`00827002304017`
Brand	Ultrathane
Model	G30401
Catalog no.	J-USCS-120025
Company	Cook Incorporated
Product code	KOB · CATHETER, SUPRAPUBIC (AND ACCESSORIES)
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	May 16, 2024

Device type (GMDN): Suprapubic drainage catheter

A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.

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All CATHETER, SUPRAPUBIC (AND ACCESSORIES) devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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