NAMIC 656000784 (UDI H9656560007840)Recalls & reported problems

Navilyst Medical, Inc. · NAMIC Convenience Kit

All models of NAMIC (41)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 H9656560007840), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Air Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Air Leak1

Patient problems

Cardiac Arrest1

Recent adverse event reports

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

InjuryNov 15, 2017Air Leak; Air Leak
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(4), HOSPITAL REPORTED THAT KINKED TUBING IN A CONVENIENCE KIT RESULTED IN AIR BUBBLES BEING INJECTED INTO THE RIGHT CORONARY ARTERY DURING A DIAGNOSTIC CORONARY ANGIOGRAPHY PROCEDURE. RESUSCITATION OF THE PATIENT WAS PERFORMED, WITH SUCCESS, AS THE PATIENT EXPERIENCED ASYSTOLE. THE PATIENT WAS GIVEN ADRENALINE. THE PATIENT'S RHYTHM PRIOR TO THE ASYSTOLE WAS SINUS RHYTHM. THE PATIENT WAS IN ASYSTOLE FOR APPROXIMATELY ONE MINUTE BEFORE THE RETURN OF CIRCULATION. THE AIR BUBBLES WERE NOT SEEN DURING PREP, NOR WERE THEY SEEN IN THE MANIFOLD PRIOR TO INJECTION. NO FOLLOW-UP CARE WAS REQUIRED, AS THE PATIENT TOTALLY RECOVERED FROM THE EVENT IN THE CATH LAB. THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Cardiac Arrest
MAUDE report 7032397 ↗

Device details

UDI-DI	`H9656560007840`
Brand	NAMIC
Model	656000784
Company	Navilyst Medical, Inc.
Product code	—
Class	—
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	Mar 29, 2018

Device type (GMDN): Angiography kit

A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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