Prelude IDeal™ 10884450381837Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Prelude IDeal (18)
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 10884450381837), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
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.
InjurySep 22, 2021Difficult to Remove; Difficult to Remove
THE ACCOUNT ALLEGES THAT AT THE CONCLUSION OF THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH FROM THE PATIENT'S ARTERY BUT HAD DIFFICULTY AND FAILED. THE PATIENT HAD AN ADDITIONAL PROCEDURE THE FOLLOWING MORNING TO REMOVE THE SHEATH, WHICH WAS DONE SUCCESSFULLY. IT WAS NOTED DURING REMOVAL THAT THE SHEATH WAS EMBEDDED IN THE ARTERY. THERE IS NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Foreign Body Embolism
MAUDE report 12513221 ↗
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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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