NAMIC 70015003Recalls & reported problems
Medline Industries, Inc. · SC 3W LP FM OFF W - PG · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489064513), received between Sep 24, 2026 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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
- Fluid/Blood Leak3
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950767 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906251 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that "We have a stopcock set up that is connected to the central lines (UVC or UAC) that we are finding to be leaking. We had another incident over night which is now the third episode."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883442 ↗
Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.