Merit Maestro® 00884450357958Recalls & reported problems

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450357958), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Nov 6, 2023Open, Classified
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Z-0627-2024 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Device problems

Material Separation1

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.

InjuryJul 13, 2022Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A CELIAC ARTERY EMBOLIZATION WHILE ATTEMPTING TO MANIPULATE THE MICROCATHETER WITHIN THE PATIENT, THE RADIOPAQUE MARKER BAND DETACHED WITHIN THE PATIENT'S TORTUOUS ANATOMY. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. THE EMBOLIZATION PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15009070 ↗

Device details

UDI-DI	`00884450357958`
Brand	Merit Maestro®
Model	00884450357958
Company	Merit Medical Systems, Inc.
Product code	KRA · Catheter, continuous flush
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	Apr 21, 2025

Device type (GMDN): Vascular microcatheter

A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). 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.