DeRoyal 31-3221Recalls & reported problems
Deroyal Industries, Inc. · Manifold 3 Port Right Hand ON · Class 2
Data updated Oct 16, 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 00749756719834), received between Mar 7, 2025 and Mar 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
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.
MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547626 ↗MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547625 ↗MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547623 ↗
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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