NAMIC 65231291Recalls & 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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965652312910), received between May 10, 2016 and May 10, 2016 — classified as 1 malfunction.

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
Fracture1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionMay 10, 2016Air Leak; Fracture; Air Leak; Fracture
END USER HOSPITAL REPORTED TO AVID MEDICAL THAT THEY SAW AIR BUBBLES IN THE LINES OF THE KIT, AS WELL AS HAVING A BROKEN (CRACKED) TRANSDUCER. THEY BELIEVE IT IS RELATED TO KINKED TUBING WITHIN THE KIT. THE USED KIT WAS DISCARDED AT THE HOSPITAL. ANGIODYNAMICS SELLS THE KIT NON-STERILE TO AVID MEDICAL WHO PROVIDES IT STERILE TO THE END USER HOSPITAL IN A PROCEDURE PACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5644385 ↗

Device details

UDI-DI	`H965652312910`
Brand	NAMIC
Model	65231291
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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