Marquis® Stopcock 00884450011324Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 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 00884450011324), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Crack; Crack
THE ACCOUNT ALLEGES THAT DURING A CATH LAB PROCEDURE, TWO STOPCOCKS HAD TO BE USED DUE TO CRACKING WHEN BEING TIGHTENED ONTO THE MANIFOLD. THEY STATED THERE WAS NO EXCESSIVE FORCE OR PRESSURE APPLIED PRIOR TO THE DEVICE CRACKING. THESE TWO STOPCOCKS WERE DISPOSED OF. A THIRD STOPCOCK WAS APPLIED WITHOUT ISSUE. AFTER THE CATH LAB PROCEDURE THE PATIENT WAS TRANSFERRED TO THE ICU PER NORMAL HOSPITAL PROTOCOL. SEVERAL HOURS LATER, THE PATIENT'S ART LINE BLOOD PRESSURE READING DROPPED. THE NURSE ENTERED THE ROOM AND NOTICED BLOOD ON THE FLOOR AND BEDSHEETS. THE NURSE PULLED BACK THE TOP SHEET AND NOTED BLOOD "SPURTING" FROM THE STOPCOCK. THE NURSE NOTED A VISIBLE CRACK IN THE STOPCOCK WHERE THE BLOOD WAS LEAKING. IT WAS REPORTED THE STOPCOCK FUNCTIONED WITHOUT ISSUE FOR SEVERAL HOURS PRIOR TO THE BLOOD LEAKAGE EVENT. THE PATIENT LATER EXPIRED DUE TO THEIR CO-MORBID CONDITIONS. THE ICU NURSE MANAGER REPORTS THE BLOOD LOSS WAS NOT THE DIRECT CAUSE OF DEATH FOR THE PATIENT BUT THAT IT "DIDN'T HELP".
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension
MAUDE report 23810388 ↗
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
- PhD™ 00884450746745Merit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall2 reports
- DLP® 14000Medtronic, 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 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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