NAMIC 88001483Recalls & reported problems
Navilyst Medical, Inc. · NAMIC 48" High Pressure Contrast Injection Line, Female to Rotating Adaptor · Class 2
Data updated Oct 13, 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 H965880014830), received between Jun 22, 2016 and Jun 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.
MalfunctionJun 22, 2016Air Leak; Connection Problem; Air Leak; Connection Problem
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4): "IT WAS REPORTED THAT WHEN DIALING BACK ON THE INJECTOR AS PART OF THE PROCEDURE SET UP, THE CONTRAST INJECTION LINE DID NOT SEEM TO BE CONNECTING CORRECTLY. THE LINE IS ATTACHED TO EITHER A 5FR OR 6FR PIGTAIL CATHETER AND THE HEALTH CARE PROFESSIONAL (HCP) NOTICED A LOT OF AIR IN THE LINE. IT WAS OBSERVED BY THE HCPS THAT MICRO AIR BUBBLES SWIRL UP THE LINE FROM THE PATIENT END." THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5742086 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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