Prelude IDeal™ 10884450684600Recalls & 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 10884450684600), received between Apr 25, 2024 and Apr 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Ischemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2024Material Deformation; Material Deformation
THE ACCOUNT ALLEGES THAT DURING AN ECMO PROCEDURE, THE MEDICAL STAFF NOTICED AN ACUTE CHANGE IN DISTAL PERFUSION WITHIN THE PATIENT'S LEG. BOTH NEAR-INFRARED SPECTROSCOPY [NIRS] AND CAPILLARY REFILL TESTING INDICATED A DECREASE IN THE DISTAL PERFUSION LINE EVEN THOUGH THE PERFUSION LINE APPEARED PATENT. THE ATTENDING PHYSICIAN EVALUATED THE PATIENT'S LEG AND EVEN THOUGH THE PATIENT WAS IMPROVING, THE PHYSICIAN FELT THAT THE BEST COURSE OF ACTION WAS TO REMOVE THE ECMO SUPPORT. THE PATIENT WAS REMOVED FROM ECMO SUPPORT AND UPON INSPECTION OF THE DISTAL PERFUSION CANNULA, IT APPEARED TO BE PATENT AND STILL INTACT HOWEVER, THERE WAS A LARGE KINK IN THE MIDDLE OF THE CANNULA THAT MAY HAVE IMPEDED SOME BLOOD FLOW DURING THE ECMO PROCEDURE. THE PATIENT REQUIRED A LEG AMPUTAITON. NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: Ischemia
MAUDE report 19181174 ↗
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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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