Prelude IDeal™ GRecalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 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 10884450844813), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Material Integrity Problem1
- Material Separation1
Patient problems
- Cramp(s) /Muscle Spasm(s)1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT IN A PATIENT WITH RIGHT RADIAL ARTERY SPASM AT THE END OF A PROCEDURE, THE DESILET INTRODUCER SYSTEM EXPERIENCED A SEPARATION BETWEEN ITS INTRAVASCULAR COMPONENT (VIOLET PART) AND THE EXTERNAL PORTION CONTAINING THE NON-RETURN VALVE (GREY PART). A FEW MILLIMETERS OF THE VIOLET SEGMENT REMAINED PROTRUDING BENEATH THE COMPRESSION BRACELET AND HAD TO BE MANUALLY GRASPED AND FORCEFULLY WITHDRAWN BY THE CARDIOLOGIST TO COMPLETE REMOVAL OF THE STENT. THE PATIENT EXPERIENCED SIGNIFICANT PAIN DURING THE EXTRACTION, WHICH WAS DIFFICULT DUE TO RESISTANCE FROM THE ARTERIAL SPASM.
Patient problems: Cramp(s) /Muscle Spasm(s); Pain
MAUDE report 22445392 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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