Prelude® 10884450615109Recalls & 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 10884450615109), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
- Obstruction/Occlusion1
- Pseudoaneurysm1
- Thrombosis/Thrombus1
- Unintended Loss of Vascular Access1
- Unspecified Infection1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PUBLISHED CLINICAL STUDY DESCRIBING USE OF THE MERIT PRELUDE SHEATH INTRODUCERS ALLEGES THAT PATIENTS EXPERIENCED MULTIPLE COMPLICATIONS ACUTE THROMBOSIS/DISSECTION,ARTERIAL ACCESS COMPLICATIONS, GROIN HEMATOMA, GROIN INFECTION, PSEUDOANEURYSM, STENT OCCLUSIONS, AND MAJOR AMPUTATIONS. NO EXPLICIT PRELUDE SHEATH MALFUNCTION WAS IDENTIFIED; EVENTS REPRESENT VASCULAR AND ACCESS-SITE COMPLICATIONS OCCURRING IN THE SETTING OF DEVICE USE.
Patient problems: Hematoma; Obstruction/Occlusion; Pseudoaneurysm; Thrombosis/Thrombus; Unintended Loss of Vascular Access; Unspecified Infection; Vascular Dissection
MAUDE report 23810435 ↗
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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
- Abiomed® 00884450732311Merit Medical Systems, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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