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NAMIC 80641242Recalls & reported problems

Navilyst Medical, Inc. · NAMIC 24" Pressure Monitoring Line, Female to Male Luer Lock · Class 1

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 H965806412420), received between Jul 10, 2017 and Jul 10, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Air Leak1

Patient problems

  • Air Embolism1

Recent adverse event reports

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

  • InjuryJul 10, 2017Air Leak; Air Leak

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), "DURING AN ANGIO PROCEDURE, IMAGES WERE TAKEN ON THE LEFT SIDED ARTERIES. THE CATHETER WAS CHANGED, ASPIRATED BACK, AND TESTED WITH NO ISSUES. ONCE ENGAGED INTO THE RCA, IMAGES WERE TAKEN AND MULTIPLE BUBBLES INJECTED DOWN ARTERY DUE TO CRACK OCCURRING AT END OF EXTENSION TUBING THAT CONNECTS TO 3-WAY TAP." IT WAS ALSO STATED THAT, "THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS." THE USED PRESSURE MONITORING LINE WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Patient problems: Air Embolism

    MAUDE report 6698912 ↗

Other MONITOR, LINE ISOLATION devices

All MONITOR, LINE ISOLATION devices →

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