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NAMIC 90703050Recalls & reported problems

Navilyst Medical, Inc. · ARTERIAL EXTENSION SET 4.5" · 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 H965907030500), received between Sep 5, 2019 and Sep 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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

  • Component Misassembled1

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 5, 2019Component Misassembled; Component Misassembled

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), BLUE NON-VENTED PORT PROTECTOR CAP CONNECTED TO STOPCOCK END PORT FITTING SHOULD HAVE BEEN A VENTED WHITE PORT PROTECTOR CAP. THE NON-VENTED CAP POSSIBLY COMPROMISES A STERILE PATHWAY FOR THIS DEVICE DURING THE STERILIZATION PROCESS. THIS ONE UNIT WAS FOUND DURING 100% INCOMING INSPECTION AT THE DISTRIBUTOR AND HAD NOT BEEN DISTRIBUTED TO A HOSPITAL.

    Patient problems: Not Applicable

    MAUDE report 8964613 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

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