NAMIC 601302211Recalls & 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 H7496013022110), received between Jul 12, 2019 and Jul 12, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood 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
- Fluid/Blood 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.
MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY HOSPITAL, THE SEAL (STOPPER) ON THE PLUNGER OF THE 10ML ANGIOGRAPHIC SYRINGE PACKAGED WITHIN THEIR CONVENIENCE KIT "IS NOT TIGHT AND THERE IS WIGGLE ROOM CAUSING AIR TO GET INTO THE SYSTEM AT THE BACK PORTION OF THE SYRINGE." THIS HAS BEEN OBSERVED DURING PREP. NO AIR HAS BEEN INJECTED INTO A PATIENT. NO SAMPLES HAVE BEEN RETAINED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8786346 ↗MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY HOSPITAL, THE SEAL (STOPPER) ON THE PLUNGER OF THE 10ML ANGIOGRAPHIC SYRINGE PACKAGED WITHIN THEIR CONVENIENCE KIT "IS NOT TIGHT AND THERE IS WIGGLE ROOM CAUSING AIR TO GET INTO THE SYSTEM AT THE BACK PORTION OF THE SYRINGE." THIS HAS BEEN OBSERVED DURING PREP. NO AIR HAS BEEN INJECTED INTO A PATIENT. NO SAMPLES HAVE BEEN RETAINED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8786345 ↗
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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