NAMIC 80038301 (UDI H749800383010)Recalls & reported problems
Navilyst Medical, Inc. · NAMIC Angiographic Medium Pressure 3 Valve Manifold, Off Handles, Ports on Right · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H749800383010), received between Apr 6, 2016 and Apr 6, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air Leak” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Air Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2016Air Leak; Air Leak
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6): END USER HOSPITAL IN (B)(6) REPORTS "AIR LEAKING INTO 3-WAY MANIFOLD CONNECTION." DEVICE IS SOLD TO (B)(6), NON-STERILE FOR FURTHER PROCESSING. NO CUSTOMER COMPLICATIONS OR INJURY WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5551884 ↗
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- RHV 23242Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass66 reports
- DLP® 14000Medtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746745Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- PhD™ 00884450746714Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
- NAMIC 64038301Medline Industries, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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