Prelude PRO™ 10884450330323Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450330323), received between Mar 23, 2022 and Mar 23, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture2
- Material Separation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE DILATOR SEPARATED INSIDE THE PATIENT AFTER INSERTION. THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHERE CT SCAN REVEALED THE DILATOR WAS LOCATED NEAR THE FEMORO-ILLIAC VEIN JUNCTURE AND WILL HAVE A PROCEDURE TO HAVE IT REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 13862683 ↗InjuryMar 23, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE GAINING SHEATH ACCESS FOR AN RF ABLATION PROCEDURE OF THE GSV, THE INTRODUCER HUB DETACHED WITHIN THE 7F ACCESS SHEATH. THE ATTENDING CLINICIAN AND STAFF DID NOT RECOGNIZE THAT THE INTRODUCER HAD DETACHED FROM THE HUB WHILE REMOVING THE ACCESS WIRE AND INTRODUCER TOGETHER AS THE LAST STEP OF THE SELDINGER ACCESS TECHNIQUE. WHEN THE CLINICIAN WAS INTRODUCING THE RF ABLATION CATHETER THROUGH THE ACCESS SHEATH, THEY INADVERTENTLY INTRODUCED THE FOREIGN BODY INTO THE PATIENT'S ILIAC VEIN. THE CLINICIAN COULD NOT IDENTIFY THE FOREIGN BODY VIA US. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR BETTER IMAGING WHERE THE LOCATION OF THE FOREIGN BODY WAS CONFIRMED. VASCULAR SURGERY WAS THEN CONSULTED, AND THE FOREIGN BODY SUCCESSFULLY EXTRACTED VIA SURGICAL TECHNIQUE THUS LIBERATING THE NEEDED VASCULAR CONDUIT FOR THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 13862525 ↗
Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices
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- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- 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
- 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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