Ring G28035Recalls & reported problems

Cook Incorporated · Ring Biliary Duct Drainage Catheter Polyethylene · Class 2 · Implant

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 00827002280359), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

Break1
Device Dislodged or Dislocated1

Patient problems

No Information1

Recent adverse event reports

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

MalfunctionNov 15, 2017Break; Device Dislodged or Dislocated
USER FOUND CATHETER DISLODGED WITH BROKEN TIP WHEN DRESSING CHANGED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 7032403 ↗

Device details

UDI-DI	`00827002280359`
Brand	Ring
Model	G28035
Catalog no.	P10.0-38-50-P-32S-RING
Company	Cook Incorporated
Product code	GCA · CATHETER, BILIARY, SURGICAL
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 19, 2020

Device type (GMDN): Biliary drain

A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). 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.