NAMIC 601308611Recalls & reported problems
Navilyst Medical, Inc. · NAMIC Convenience Kit
All models of NAMIC (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H9656013086110), received between Aug 10, 2016 and Sep 26, 2016 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air Leak” (3 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Air Leak3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2016Air Leak; Air Leak
AS REPORTED, WHILE UTILIZING A CONVENIENCE KIT, " AIR WAS LEAKING INTO THE MANFOLD SYSTEM." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. THE USED SAMPLE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5976612 ↗MalfunctionAug 10, 2016Air Leak; Air Leak
AS REPORTED, WHILE USING A CONVENIENCE KIT DURING AN ANGIOGRAPHIC PROCEDURE, AN AIR LEAK WAS NOTED. NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. A DEVICE SAMPLE HAS BEEN RETURNED TO ANGIODYANMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5864487 ↗MalfunctionAug 10, 2016Air Leak; Air Leak
AS REPORTED, WHILE USING A CONVENIENCE KIT DURING AN ANGIOGRAPHIC PROCEDURE, AN AIR LEAK WAS NOTED. NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. A DEVICE SAMPLE HAS BEEN RETURNED TO ANGIODYANMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5864482 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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