NAMIC 60191011Recalls & 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 H965601910110), received between May 20, 2019 and May 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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
- Improper Flow or Infusion2
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.
MalfunctionMay 20, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED, WITH A CONVENIENCE KIT, AIR BUBBLES WERE BELIEVED TO BE ENTERING THE LINE AT THE CONNECTION OF THE DISPOSABLE TRANSDUCER AND THE PRESSURE MONITORING LINE. "THE CONNECTIONS WERE THEN TIGHTENED, AND EVENTUALLY CHANGED OUT." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. SAMPLES ARE BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8623261 ↗MalfunctionMay 20, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED, WITH A CONVENIENCE KIT, AIR BUBBLES WERE BELIEVED TO BE ENTERING THE LINE AT THE CONNECTION OF THE DISPOSABLE TRANSDUCER AND THE PRESSURE MONITORING LINE. "THE CONNECTIONS WERE THEN TIGHTENED, AND EVENTUALLY CHANGED OUT." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. SAMPLES ARE BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8623260 ↗
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