NAMIC 70055009 (UDI 10193489065695)Recalls & reported problems
Medline Industries, Inc. · SC 3W HP RA OFF NB - PG · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489065695), received between Aug 18, 2023 and Sep 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem2
- Gas/Air Leak1
- Material Too Rigid or Stiff1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952285 ↗MalfunctionSep 29, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936133 ↗MalfunctionSep 2, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566239 ↗MalfunctionAug 12, 2026Material Too Rigid or Stiff
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228846 ↗MalfunctionAug 18, 2023
ELDERLY MALE WITH HISTORY OF ATRIAL FIBRILLATION. PROCEDURE: ELECTROPHYSIOLOGY STUDY WITH ABLATION. 3-WAY STOPCOCK WAS LEAKING ON THE LUER LOCK SIDE, WHICH COULD HAVE INTRODUCED AIR. TRIED TO PROBLEM SOLVE SOURCE AND CHANGED THE IV TUBING BUT IT STILL WAS LEAKING AIR. THE STOPCOCK WAS CHANGED AND THERE WAS NO FURTHER LEAKING. NO KNOWN HARM TO THE PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR STOPCOCK, NAMIC (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17571530 ↗
Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices
- Indeflator 1003327Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls722 reports
- Copilot 1003331Abbott Vascular Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass189 reports
- DLP® 11001GMedtronic, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass2 recalls0 reports
- 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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