Prelude SNAP™ 10884450467999Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450467999), received between Dec 15, 2022 and Oct 21, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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.

• MalfunctionOct 21, 2025Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation

  THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH AT THE VALVE-RING. THE PROVIDER HAD TO CUT AND SLICE THE VALVE-RING BY HAND IN ORDER TO REMOVE THE SHEATH FROM THE IMPLANTED LEAD. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349575 ↗
• DeathDec 15, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE ACCOUNT ALLEGES THAT POST- CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR [CRT-D] IMPLANT PROCEDURE, THE PATIENT EXPIRED IN THE RECOVERY UNIT. THE PHYSICIAN ALLEGES THAT AT THE BEGINNING OF THE CRT-D IMPLANT CASE, THE STOPCOCK ON THE SHEATH INTRODUCER WAS IN THE OPEN POSITION AND AIR WAS NOTED WITHIN THE TUBING OF THE INTRODUCER SHEATH. THE DEVICE WAS STILL USED FOR ACCESS DURING THE CASE AND ANESTHESIA STABILIZED THE PATIENT DURING THE PROCEDURE. THE PHYSICIAN ALLEGES THAT AIR MAY HAVE BEEN INTRODUCED INTO THE PATIENT'S SUBCLAVIAN VEIN AND MIGRATED DURING SHEATH PLACEMENT. THE PATIENT WOULD NOT STOP COUGHING AT TIMES DURING THE PROCEDURE, AND O2 SATURATIONS HAD DROPPED. THE CRT-D DEVICE WAS SUCCESSFULLY IMPLANTED AND TESTED. ALL PACING PARAMETERS HAD BEEN SET CORRECTLY AND THE DEFIBRILLATOR WAS CAPTURING AS INTENDED. THE CRT-D IMPLANT PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS TRANSFERRED TO A RECOVERY UNIT FOR OBSERVATION IN STABLE CONDITION. THE PATIENT EXPIRED AT SOME TIME DURING RECOVERY. THE CAUSE OF DEATH IS UNKNOWN. A HOSPITAL INVESTIGATION IS CURRENTLY UNDERWAY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990692 ↗