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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

Sources and updates

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