Prelude® 10884450331870Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Prelude (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450331870), received between Apr 14, 2021 and Apr 14, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES PRELUDE INTRODUCER WAS FOUND AT THE DISTRIBUTION CENTER WITH A DAMAGED STERILITY BARRIER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11668067 ↗MalfunctionApr 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES PRELUDE INTRODUCER WAS FOUND AT THE DISTRIBUTION CENTER WITH A DAMAGED STERILITY BARRIER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11668045 ↗
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- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 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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