Prelude® Short Sheath 10884450015398Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450015398), received between Jul 24, 2024 and Sep 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionSep 3, 2024Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT WHEN INSERTED INTO PATIENT WITH CONTRAST INJECTION, THE 6FR GREEN CAP AND ANTI-REFLUX VALVE DISCONNECTED FROM THE HUB OF THE SHEATH AND BLEW BACK ONTO THE WIRE THAT WAS USED TO MAINTAIN ACCESS INTO THE VESSEL. THE PATIENT HAD SOME BLOOD FLOWING OUT FROM THE HUB OF THE SHEATH BUT WAS CONTROLLED BEFORE SIGNIFICANT BLEEDING COULD OCCUR AND WITH NO SIGNIFICANT HARM TO THE PATIENT. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY FURTHER OCCURRENCES OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127001 ↗InjuryJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE MARKER TIP CAME OFF INSIDE THE PATIENT BUT WAS PROMPTLY REMOVED WITHOUT CAUSING ANY HARM.
Patient problems: Foreign Body In Patient
MAUDE report 19816797 ↗
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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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