Honor® 00884450013137Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450013137), received between Oct 14, 2020 and Oct 17, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2023
DURING INJECTION OF CONTRAST INTO THE RIGHT PULMONARY VEIN, THE HEMOSTATIC VALVE SEPARATED INTO TWO PIECES. NO AIR WAS INTRODUCED, THE CATHETER AND VALVES WERE REMOVED, NEW VALVE ATTACHED, AND THE STUDY WAS COMPLETED. MANUFACTURER RESPONSE FOR ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS, HONOR (PER SITE REPORTER). VENDOR REP WAS NOTIFIED. REMAINING STOCK FROM LOT WAS REMOVED FROM USE.
Patient problems: Insufficient Information
MAUDE report 17949089 ↗MalfunctionOct 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE ACCOUNT ALLEGES THAT THERE WAS WHITE PLASTIC DEPOSIT WITHIN THE VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10680961 ↗
Other Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices
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- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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