Prelude SNAP™ 10884450468156Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450468156), received between Jul 29, 2025 and Jul 29, 2025 — classified as 2 malfunctions.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 11, 2024Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2574-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 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 LEFT VENTRICLE THROUGH THE SUBCLAVIAN VEIN. THE DEVICE WAS USED FOR APPROXIMATELY 25 MINUTES. DURING THIS TIME THE PATIENT EXPERIENCED A PNEUMOTHORAX. NO ADDITIONAL TREATMENT WAS REQUIRED NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Hemothorax

  MAUDE report 22647398 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 MALE PATIENT 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 ATRIUM THROUGH THE FEMORAL VEIN. THE DEVICE WAS USED FOR APPROXIMATELY 34 MINUTES. DURING THIS TIME THE PATIENT EXPERIENCED A HEMOTHORAX. NO ADDITIONAL TREATMENT WAS REQUIRED NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Hemothorax

  MAUDE report 22647396 ↗