NAMIC 656608724Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H7496566087240), received between Jan 5, 2018 and Jan 5, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air Leak” (2 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 Leak2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2018Air Leak; Air Leak
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), HOSPITAL USING AN ANGIODYNAMICS KIT PROVIDED IN A (B)(6) PROCEDURE PACK REPORTED AIR BUBBLES IN THE CONTRAST LINE, POST FLUSHING OF THE LINE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED SAMPLES WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7169713 ↗MalfunctionJan 5, 2018Air Leak; Air Leak
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), HOSPITAL USING AN ANGIODYNAMICS KIT PROVIDED IN A (B)(6) PROCEDURE PACK REPORTED AIR BUBBLES IN THE CONTRAST LINE, POST FLUSHING OF THE LINE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED SAMPLES WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7169673 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page