PhD™ 00884450746745Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450746745), received between May 20, 2024 and Jun 13, 2024 — classified as 2 malfunctions.
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 4, 2025Open, Classified
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Z-0533-2026 · Root cause: Process change control · FDA record ↗
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2024
TRIED FLUSHING THE COPILOT, WOULD NOT FLUSH OUT THE BACK END OF THE COPILOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19527230 ↗MalfunctionMay 20, 2024
AT THE END OF PROCEDURE, TECH NOTICED AIR BUBBLES IN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351407 ↗
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- 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
- 10Fore™ Initial ReleaseMerit Medical Systems, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.