NAMIC 60033413Recalls & 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: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965600334130), received between Jun 13, 2016 and Jun 13, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air Leak” (2 reports).

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 Leak2

Patient problems

No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 13, 2016Air Leak; Air Leak
AS REPORTED, WHEN CONVENIENCE KIT WAS BEING UTILIZED IN THE CATH LAB, IT WAS NOTED THAT AIR WAS BEING INTRODUCED INTO THE SYSTEM AND "BACK FLOWING INTO THE TRANSDUCER LINE." NO PATIENT INJURY WAS REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYANAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5720186 ↗
MalfunctionJun 13, 2016Air Leak; Air Leak
AS REPORTED, WHEN CONVENIENCE KIT WAS BEING UTILIZED IN THE CATH LAB, IT WAS NOTED THAT AIR WAS BEING INTRODUCED INTO THE SYSTEM AND "BACK FLOWING INTO THE TRANSDUCER LINE." NO PATIENT INJURY WAS REPORTED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYANAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5720181 ↗

Device details

UDI-DI	`H965600334130`
Brand	NAMIC
Model	60033413
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	Sep 3, 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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