NAMIC 65191157Recalls & 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 H749651911570), received between May 29, 2018 and May 29, 2018 — 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

ST Segment Elevation1

Recent adverse event reports

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

InjuryMay 29, 2018Air Leak; Air Leak
AS REPORTED BY HOSPITAL, PATIENT WAS BROUGHT TO THE REDIAL CATH LAB ON (B)(6) 2018 FOR A CORONARY ANGIOGRAM WHICH TURNED INTO A PERCUTANEOUS CORONARY INTERVENTION. THE LEAK IN THE Y-ADAPTOR CAUSED AN AIR INJECTION INTO THE CORONARY VESSELS RESULTING IN AN ST-ELEVATION WITH HEMODYNAMIC CHANGES. THERE WAS NO DELAY OF CARE, CARE WAS IMMEDIATE, NO ADDITIONAL INJURY OR MEDICAL TREATMENT WAS NEEDED. THE PATIENT WAS SEEN ON (B)(6) 2018 FOR A FOLLOW-UP AND WAS DOING FINE. THE USED Y-ADAPTOR WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: ST Segment Elevation
MAUDE report 7549068 ↗

Device details

UDI-DI	`H749651911570`
Brand	NAMIC
Model	65191157
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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