Prelude SNAP™ 10884450467951Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884450467951), received between Nov 10, 2020 and Nov 7, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 16, 2026.

Recalls naming this device

1. Jun 11, 2024Open, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Integrity Problem; Material Integrity Problem

  THE ACCOUNT ALLEGES THE DEVICE FAILED TO SPLIT CORRECTLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498059 ↗
• MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909965 ↗
• MalfunctionMay 16, 2025Separation Failure; Separation Failure

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE 6F PRELUDE SNAP SHEATH DID NOT PEEL APART PROPERLY REQUIRING THE CLINICIAN TO IT AWAY BEFORE CONTINUING THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033533 ↗
• MalfunctionJan 26, 2024

  ELDERLY FEMALE WITH CORONARY ARTERY DISEASE AND HYPERTENSION. PROCEDURE: DUAL ICD (IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR) IMPLANTATION- WHEN PACKAGE WAS OPENED, DILATOR WAS NOT TAPERED AT THE END. NO TIP FOUND IN PACKAGING. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE SNAP (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586402 ↗
• MalfunctionFeb 14, 2023Complete Blockage; Structural Problem

  EARLY 70¿S MALE WITH HISTORY OF TACHYCARDIA SYNDROME. PROCEDURE: IMPLANTATION OF RIGHT SIDED DUAL CHAMBER PACEMAKER. THE DILATOR OF MERIT 6F PRELUDE SNAP SHEATH IS NOT OPEN ON THE TIP. IT WAS NOT USABLE, COULD NOT THREAD THE WIRE. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE SNAP¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371443 ↗
• MalfunctionNov 10, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE ACCOUNT ALLEGES THAT DURING A PACEMAKER LEAD EXTRACTION AND UPGRADE, THE PRELUDE PEEL AWAY SHEATH WAS USED TO MAINTAIN VENOUS ACCESS AND SUTURED DOWN. DURING REMOVAL, THE TOP OF THE SHEATH BROKE AWAY. THE SURGEON CUT DOWN THE INCISION SITE TO REMOVE THE BROKEN OFF SHEATH. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820168 ↗