NAMIC 65141392Recalls & 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: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965651413920), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Leak/Splash” (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

Leak/Splash1

Patient problems

Air Embolism1
Death1

Recent adverse event reports

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

DeathJun 21, 2019Leak/Splash; Leak/Splash
AS REPORTED BY CATH LAB MANAGER, ONE OF THE HOSPITAL'S PHYSICIANS INJECTED AN AIR BUBBLE INTO A PATIENT ON (B)(6) 2019 DURING A CASE. AN AIR BUBBLE HAD BEEN OBSERVED IN THE SYRINGE NEAR THE PLUNGER. THE PATIENT WAS HAVING THE PROCEDURE DUE TO AN "EMERGENT STEMI CASE" AND PASSED AWAY DURING THE PROCEDURE. THE CAUSE OF DEATH AND RELATIONSHIP TO THIS EVENT (IF ANY) HAS NOT BEEN PROVIDED TO ANGIODYNAMICS YET. ANGIODYNAMICS HAS MADE MULTIPLE ATTEMPTS TO CONTACT PERSONNEL AT THE HOSPITAL, BUT THEY HAVE, AS OF YET, BEEN UNAVAILABLE. THE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE CONTINUING. THE PRODUCTS USED DURING THE PROCEDURE HAVE BEEN DISPOSED OF AT THE HOSPITAL.
Patient problems: Air Embolism; Death
MAUDE report 8723209 ↗

Device details

UDI-DI	`H965651413920`
Brand	NAMIC
Model	65141392
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	Oct 8, 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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