Prelude PRO™ 10884450331108Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450331108), received between Dec 15, 2020 and Dec 15, 2020 — 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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2020Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT ON (B)(6) 2020 THE RADIOPAQUE TIP FROM THE PRO-5F-11MT/C SHEATH DETACHED WITHIN THE PATIENT SFA/ANTERIOR TIBIAL [AT] ARTERY AND OCCLUDED A VENOUS BYPASS GRAFT WITHIN THE PATIENT'S DISTAL PERIPHERY. THE VESSEL WAS NOT DISEASED, AND AN ANGIOPLASTY WAS PERFORMED THROUGH THIS SHEATH DURING THIS PROCEDURE. POST-PROCEDURE THE PATIENT WAS DISCHARGED TO HOME. ON (B)(6) 2020 DURING A FOLLOW-UP APPOINTMENT WITH THE PATIENT. AN ULTRASOUND DEMONSTRATED THAT APPROX. 7MM RADIOPAQUE MARKER BAND WAS OCCLUDING THE DISTAL VEIN GRAFT ALONG WITH A COLLECTION OF THROMBI. ON (B)(6) 2020 THE PATIENT UNDERWENT A THROMBOLYSIS PROCEDURE TO BREAK DOWN AND REMOVE THE THROMBUS/CLOTS. THE GRAFT WAS CLEARED OF THROMBUS/CLOTS, BUT FRESH CLOTS WERE IDENTIFIED. THE FOREIGN BODY REMAINED IN-SITU. ON (B)(6) 2020 THE PATIENT WAS REFERRED TO VASCULAR SURGEON, WHERE THE FOREIGN BODY WAS SUCCESSFULLY REMOVED VIA SURGICAL PROCEDURE.
Patient problems: Foreign Body Embolism
MAUDE report 11013564 ↗
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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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