Prelude® Short Sheath 10884450015404Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450015404), received between Aug 12, 2020 and Nov 29, 2022 — classified as 2 injuries.
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
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING VASCULAR ACCESS FOR A PROCEDURE, THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT'S BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15882958 ↗InjuryAug 12, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A G-CLOT FISTULA PROCEDURE, THE WIRE BROKE OFF INSIDE THE PATIENT. A SNARE WAS REQUIRED TO REMOVE THE DETACHED TIP.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10398860 ↗
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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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