Prelude® 10884450050726Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Prelude (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450050726), received between Sep 3, 2024 and Jul 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING THE OPERATION OF THE ECMO ARTIFICIAL CARDIOPULMONARY MACHINE, THE SIDEARM TUBING OF THE SHEATH DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569714 ↗MalfunctionSep 3, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING AN ECMO PROCESS IN THE ICU, THE NURSE FOUND BLOOD COMING FROM A PUNCTURE WHILE CLEANING THE PATIENT'S GROIN AREA. THE CLINICIAN WAS CALLED IN TO EXAMINE THE PATIENT. UPON INVESTIGATION IT WAS DISCOVERED THE SIDE OF THE SHEATH WAS CRACKED AND LEAKING BLOOD. A SPECIALIST WAS CALLED IN TO RESET THE SHEATH. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20131243 ↗
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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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