Prelude® 10884450013769Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Prelude (22)
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 10884450013769), received between May 15, 2024 and May 15, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2024Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT WHEN THE PHYSICIAN USED THE 7F SHEATH FOR CONTRAST SURGERY, THE PATIENT'S BLOOD VESSELS WERE SPASMODIC. AFTER THE SPASMODIC STOPPED, THE SHEATH WAS PULLED OUT FROM BODY AND IT WAS FOUND THAT THE SHEATH WAS BROKEN AND A PART OF IT REMAINED IN THE PATIENT'S BODY. LATER, OTHER DEVICES WERE USED TO HELP PULL OUT THE REST OF THE PIECES.
Patient problems: Foreign Body In Patient
MAUDE report 19320544 ↗
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- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- 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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