Prelude SNAP™ 10884450251505Recalls & reported problems
Merit Medical · Class 2
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 10884450251505), received between Aug 5, 2025 and Aug 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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
- Difficult or Delayed Separation1
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
- Unsealed Device Packaging1
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.
MalfunctionAug 27, 2025Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem
THE ACCOUNT ALLEGES THAT SEAL OF THE PACKAGING WAS OPEN. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909990 ↗MalfunctionAug 5, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THE DEVICE SEAL DID NOT COMPLETELY BREAK AND REQUIRED CUTTING AWAY THE RING SEAL FROM THE LEAD. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717376 ↗
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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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