Prelude SNAP™ 00884450251492Recalls & 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 00884450251492), received between Jul 29, 2025 and Jul 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (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.
Reports received per month
Most reported problems
Device problems
- Separation Failure2
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.
MalfunctionJul 29, 2025Separation Failure; Separation Failure
ON (B)(6), 2025, A MERIT EMPLOYEE CONDUCTED A PMCF REVIEW FOR THE PRELUDE SNAP PRODUCT FAMILY. A PRELUDE SNAP SPLITTABLE SHEATH INTRODUCER WAS USED TO TREAT A FEMALE PATIENT >55 FOR THE INTRODUCTION OF SECONDARY DEVICE (E.G., PACING LEADS, CATHETERS) INTO THE HEART OR CORONARY VENOUS SYSTEM . THE PRIMARY USAGE OF THE DEVICE WAS TO FACILITATE PLACEMENT OF A DEVICE IN THE RIGHT VENTRICLE THROUGH THE V. CEPHALICA. THE DEVICE WAS USED FOR APPROXIMATELY 15 MINUTES. DURING THIS TIME THE PATIENT EXPERIENCED NO COMPLICATIONS. NO ADDITIONAL TREATMENT WAS REQUIRED HOWEVER, THE INNER SEALING RING DOES NOT BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647400 ↗MalfunctionJul 29, 2025Separation Failure; Separation Failure
THE ACCOUNT ALLEGES DURING AN IMPLANT PROCEDURE, THE RA LEAD WAS INSERTED THROUGH THE SHEATH TO THE TARGET (RA APPENDAGE). WHEN THEY PHYSICIAN ATTEMPTED TO PEEL THE SHEATH IS TORE IN A SPIRAL MANNER STILL COVERING THE LEAD. THE PHYSICIAN HAD TO CAREFULLY CUT THE REST OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647397 ↗
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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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