ONE Snare® 00884450122921Recalls & reported problems

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 00884450122921), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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

Material Separation1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

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

InjuryMar 26, 2026Material Separation
CUSTOMER ALLEGED DURING AN ENDOSCOPIC THIRD VENTRICULOSTOMY (EVT) PROCEDURE, THE LOOP OF THE PRODUCT DETACHED DURING AN ATTEMPT TO GRASP THE GUIDEWIRE AND TEMPORARILY REMAINED IN THE PATIENT'S BODY.A SECOND PRODUCT FROM THE SAME LOT WAS OPENED, ALLOWING RETRIEVAL OF THE DETACHED LOOP, AND THE PROCEDURE WAS COMPLETED USING THE OPENED GUIDEWIRE. THE PATIENT INJURY WAS A TEMPORARY IN-BODY RETENTION.
Patient problems: Foreign Body In Patient
MAUDE report 24699169 ↗

Device details

UDI-DI	`00884450122921`
Brand	ONE Snare®
Model	00884450122921
Catalog no.	ONE401
Company	Merit Medical Systems, Inc.
Product code	MMX · Device, percutaneous retrieval
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 25, 2025

Device type (GMDN): Intravascular extraction catheter-snare

A flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

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