Prelude® 10884450015107Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450015107), received between Oct 20, 2022 and Oct 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Material Separation2
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.
MalfunctionOct 20, 2022Fracture; Material Separation; Fracture; Material Separation
CUSTOMER REPORTS THAT DURING A PROCEDURE THE SHEATH FELL OFF THE RADIOPAQUE TIP. NO WIRES OR BALLONS WERE PUT THROUGH THE SHEATH. IT FELL OFF WHEN THE SHEATH WAS REMOVED. THE OTHER SHEATH AFTER THE 0.18 WIRE WAS REMOVED IT WAS LIKE THE COVER ON THE END OF THE SHEATH WOULD NOT SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638459 ↗MalfunctionOct 20, 2022Fracture; Material Separation; Fracture; Material Separation
CUSTOMER REPORTS THAT DURING A PROCEDURE THE SHEATH FELL OFF THE RADIOPAQUE TIP. NO WIRES OR BALLONS WERE PUT THROUGH THE SHEATH. IT FELL OFF WHEN THE SHEATH WAS REMOVED. THE OTHER SHEATH AFTER THE 0.18 WIRE WAS REMOVED IT WAS LIKE THE COVER ON THE END OF THE SHEATH WOULD NOT SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638441 ↗
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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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