LITHOSTENT 5637028Recalls & reported problems

Gyrus ACMI, LLC · 7.0FR(2.3mm) X 28 cm LITHOSTENT URETERAL STENT TECOFLEX · 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 00821925005129), received between Jan 1, 2024 and Jan 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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

Packaging Problem1

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.

MalfunctionJan 1, 2024Packaging Problem; Packaging Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE LITHOSTENT HAD A CRUSHED PACKAGE ON TRANSPORT. THE STERILITY WAS COMPROMISED. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18423320 ↗

Device details

UDI-DI	`00821925005129`
Brand	LITHOSTENT
Model	5637028
Company	Gyrus ACMI, LLC
Product code	FAD · Stent, Ureteral
Class	Class 2
FDA submission	K960148
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	Sep 2, 2024

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.