Prelude EASE™ 10884450289386Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450289386), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2019Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING RADIAL ARTERY ACCESS FOR A PERCUTANEOUS CORONARY INTERVENTION [PCI] PROCEDURE, THE INTRODUCER HUB DETACHED WHEN REMOVING THE VASCULAR ACCESS GUIDEWIRE AND SHEATH INTRODUCER AFTER ACQUIRING SUCCESSFUL VASCULAR SHEATH ACCESS. THE REMAINING INTRODUCER WAS SUCCESSFULLY REMOVED FROM THE LUMEN OF THE SHEATH WITH A PAIR OF HEMOSTATS. THE SHEATH WAS SUCCESSFULLY USED FOR THE PCI PROCEDURE. NO PATIENT INJURY TO REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9501079 ↗
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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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