Merit® Manifold 00884450018965Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00884450018965), received between Feb 17, 2021 and Jul 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. 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
- Tear, Rip or Hole in Device Packaging3
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.
MalfunctionJul 29, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES BEFORE USE THE DEVICE PACKAGING WAS FOUND TO BE DAMAGED. NO PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22650580 ↗MalfunctionDec 5, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING PROCESSES RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20857047 ↗MalfunctionFeb 17, 2021Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT DURING PREPARATIONS FOR A PROCEDURE, A HOLE IN THE CLEAR FILM CAUSING A BREACH WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11338090 ↗
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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