DeRoyal 77-301607Recalls & reported problems
Deroyal Industries, Inc. · 48" HIGH PRESSURE LINE W/RA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756168847), received between Feb 6, 2019 and Feb 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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.
Most reported problems
Device problems
- Complete Blockage1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2019Complete Blockage
THE END USER WAS UNABLE TO REMOVE AIR BUBBLES FROM TWO HIGH PRESSURE LINES FROM THE SAME LOT NUMBER. A THIRD LINE WAS OPENED FROM A DIFFERENT LOT NUMBER TO COMPLETE THE CASE. THE PRODUCT WAS BEING USED ON A POWER INJECTOR DURING A HEART CATHETERIZATION PROCEDURE. THE PATIENT DIED; HOWEVER, THE END USER STATED THE HIGH PRESSURE LINE DID NOT CAUSE THE PATIENT TO DECEASE AS THE PATIENT SUFFERED MANY HEALTH ISSUES.
Patient problems: Death
MAUDE report 8310102 ↗
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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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