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NAMIC 80085007 (UDI H965800850070)Recalls & reported problems

Navilyst Medical, Inc. · NAMIC Angiographic 10 ml Control Syringe · Class 2

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 H965800850070), received between Dec 22, 2016 and Dec 22, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Air Leak1
  • Connection Problem1

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.

  • MalfunctionDec 22, 2016Air Leak; Connection Problem; Air Leak; Connection Problem

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), "CONTROL SYRINGE WOULD NOT MAKE A SECURE CONNECTION TO MANIFOLD AND BUBBLES WERE PRESENT IN SET-UP." THIS WAS NOTED DURING SET-UP AND THE PRODUCT WAS NOT USED ON A PATIENT. THE DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6198614 ↗

Other INJECTOR AND SYRINGE, ANGIOGRAPHIC devices

All INJECTOR AND SYRINGE, ANGIOGRAPHIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.