DeRoyal 60-3225Recalls & reported problems
Deroyal Industries, Inc. · Manifold 3 Port Right Hand, OFF · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756719919), received between Mar 7, 2025 and Aug 20, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Air Embolism1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2025Crack; Crack
A DISTRIBUTING FACILITY REPORTED THROUGH MEDWATCH #1423395-2025-00089, "DEFECTIVE MANIFOLD." FOLLOW UP INFORMATION OBTAINED FROM EMAIL ALSO STATED, "SUSPECTED AIR EMBOLISM INTRODUCED THROUGH DEFECTIVE MANIFOLD." THE CUSTOMER REPORTED THAT THERE WAS A "CRACK ON THE END OF THE MANIFOLD WHERE CONNECTING TUBE CONNECTS TO MANIFOLD GOING TO CATHETER".
Patient problems: Air Embolism
MAUDE report 22852946 ↗MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547627 ↗MalfunctionMar 7, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547622 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.