Prelude PRO™ 10884450602932Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450602932), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Air/Gas in Device” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device1
Patient problems
- Air Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2024Air/Gas in Device; Air/Gas in Device
THE ACCOUNT ALLEGES THE HEMOSTASIS VALVE OF THE SHEATH MALFUNCTIONED WHICH RESULTED IN AN AIR EMBOLISM BEING INTRODUCED INTO THE PATIENT. THE PATIENT EXPERIENCED NUMBNESS IN THE HAND AND LOST COLOR IN THE LEG. THE SHEATH WAS DISCARDED DUE TO CONTAMINATION WITH BODILY FLUIDS.
Patient problems: Air Embolism
MAUDE report 20726045 ↗
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- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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