NAMIC 606209316Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H9656062093160), received between Jul 20, 2016 and Jul 31, 2019 — classified as 1 injury, 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
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- Ischemia1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2019Fracture; Fracture
AS REPORTED BY HOSPITAL IN THE (B)(6), WHILE USING AN ANGIOGRAPHIC CONVENIENCE KIT, " THE PATIENT HAS HAD CHEST PAINS / ISCHEMIA AND ST ELEVATIONS AFTER AIR HAS ENTERED THE CORONARY. PATIENT HAS RECOVERED." THE DEVICE USED IN THE REPORTED PROCEDURE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Ischemia
MAUDE report 8845237 ↗MalfunctionJul 20, 2016Air Leak; Air Leak
AS REPORTED BY (B)(6) DISTRIBUTOR IN THE (B)(6), WHILE USING A CONVENIENCE KIT DURING A PCI PROCEDURE, THE END USER NOTED LEAKAGE AT THE BONDED CONNECTION SITE BETWEEN THE MANIFOLD AND THE CONTRAST INJECTION LINE RESULTING IN AIR ENTERING THE SYSTEM. THE TWO COMPONENTS WERE CROOKED AT THE BONDED CONNECTION. NO AIR INJECTION OR PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5809792 ↗MalfunctionJul 20, 2016Air Leak; Air Leak
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), WHILE USING A CONVENIENCE KIT DURING A PCI PROCEDURE, THE END USER NOTED LEAKAGE AT THE BONDED CONNECTION SITE BETWEEN THE MANIFOLD AND THE CONTRAST INJECTION LINE RESULTING IN AIR ENTERING THE SYSTEM. THE TWO COMPONENTS WERE CROOKED AT THE BONDED CONNECTION. NO AIR INJECTION OR PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5809790 ↗
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