Universa G49953Recalls & reported problems

Cook Incorporated · Universa Soft Ureteral Stent Set with Hydrophilic Coating · Class 2 · Implant

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002499539), received between Apr 12, 2018 and May 30, 2019 — classified as 2 malfunctions.

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

Calcified1
Device Damaged Prior to Use1
Difficult to Remove1
Material Deformation1
Split1

Patient problems

No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 30, 2019Calcified; Difficult to Remove; Material Deformation; Calcified; Difficult to Remove; Material Deformation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8655079 ↗
MalfunctionApr 12, 2018Device Damaged Prior to Use; Split
THE COMPLAINANT REPORTED THAT A 1CM (CENTIMETER) SLIT WAS FOUND AT THE END OF THE UNIVERSA SOFT URETERAL STENT AFTER OPENING. IT WAS FURTHER NOTED THAT THE DISTAL END OF THE STENT WAS TORN FROM THE FIRST SIDEPORT THROUGH THE TIP. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7427067 ↗

Device details

UDI-DI	`00827002499539`
Brand	Universa
Model	G49953
Catalog no.	USH-700
Company	Cook Incorporated
Product code	FAD · STENT, URETERAL
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Polymeric ureteral stent

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

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