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NAMIC 64038200 (UDI H965640382000)Recalls & reported problems

Navilyst Medical, Inc. · NAMIC Angiographic Medium Pressure 2 Valve Manifold, Off Star Handles, Ports on Right · 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 H965640382000), received between Sep 21, 2016 and Sep 21, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • Not Applicable1

Recent adverse event reports

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

  • MalfunctionSep 21, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A MANIFOLD POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: Not Applicable

    MAUDE report 5966425 ↗

Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

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