Prelude SNAP™ 10884450467982Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884450467982), received between Dec 15, 2021 and May 8, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Device Fell

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN REMOVING THE SHEATH, THE PLASTIC DISC FELL OFF INTO THE INSERTION SITE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127092 ↗
• MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem

  THE ACCOUNT ALLEGES WHEN ATTEMPTING TO SPLIT THE SHEATH THE VALVE WILL NOT SPLIT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480651 ↗
• MalfunctionOct 21, 2025Break; Fracture; Separation Failure; Activation, Positioning or Separation Problem; Material Integrity Problem; Separation Problem; Difficult or Delayed Separation; Break; Fracture; Separation Failure; Activation, Positioning or Separation Problem; Material Integrity Problem; Separation Problem; Difficult or Delayed Separation

  THE ACCOUNT ALLEGES THAT WHEN SPLITTING THE SHEATH, ONE OF THE HANDLES BROKE OFF SO THE SHEAT COULD NOT BE PEELED ANYMORE. THE PROVIDER HAD TO CUT AND SLICE THE SHEATH 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 23351393 ↗
• 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 THE SHEATH FAILED TO PEEL AFTER THE PROBE WAS INSERTED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349578 ↗
• 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 23349576 ↗
• 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 23349574 ↗
• MalfunctionSep 10, 2025Material Integrity Problem; Material Integrity Problem

  CUSTOMER REPORTS HAVING A COUPLE OF PRELUDE SNAP SHEATHS NOT SPLITTING PROPERLY AND THE LITTLE VALVE IS FALLING OUT INTO THE PATIENT POCKET. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017695 ↗
• MalfunctionJul 22, 2025Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT THE WIRE BROKE DURING INSERTION. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569700 ↗
• MalfunctionJul 22, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE ACCOUNT ALLEGES THAT WHEN SPLITTING THE SHEATH BOTH "WINGS"/HANDLES BROKE OFF. THE CUSTOMER HAD TO CUT/SLICE THE SHEATH BY HAND. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569692 ↗
• MalfunctionJul 3, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE WHILE SPLITTING THE SHEATH THE VALVE-RING DIDN'T BREAK. THE CLINICIAN HAD TO CUT/SLICE THE VALVE-RING BY HAND TO BE ABLE TO REMOVE THE SHEATH FROM THE IMPLANTED LEAD. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396574 ↗
• MalfunctionJun 18, 2025Separation Failure; Separation Failure

  THE ACCOUNT ALLEGES THAT THE MATERIAL OF THE SHEATH WASN'T FIRM/SOLID ENOUGH TO BE SPLIT COMPLETELY BUT WAS RAGGED/BROKE SO THEY HAD TO SLICE THE WALL WITH A KNIFE/SCISSOR TO BE ABLE TO REMOVE THE SHEATH AND COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286384 ↗
• MalfunctionJun 3, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT A PORTION OF THE SHEATH BROKE OFF AND REMAINED IN THE PATIENT'S PERMANENT PACEMAKER POCKET DURING AN IMPLANT PROCEDURE UNTIL NOTICED BY THE PHYSICIAN. THE FOREIGN BODY THAT DETACHED WITHIN THE PATIENT'S POCKET WAS EASILY REMOVED BY PHYSICIAN'S HAND. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136282 ↗
• MalfunctionJun 3, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT A PORTION OF THE SHEATH BROKE OFF AND REMAINED IN THE PATIENT'S PERMANENT PACEMAKER POCKET DURING AN IMPLANT PROCEDURE UNTIL NOTICED BY THE PHYSICIAN. THE FOREIGN BODY THAT DETACHED WITHIN THE PATIENT'S POCKET WAS EASILY REMOVED BY PHYSICIAN'S HAND. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136281 ↗
• MalfunctionMay 28, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE ACCOUNT ALLEGES THAT THEY EXPERIENCED PROBLEMS WHILE SPLITTING AND PEELING THE SHEATH. THE MATERIAL OF THE SHEATH WASN'T FIRM/SOLID ENOUGH TO BE SPLIT COMPLETELY. WHEN THEY SPLIT THE SHEATH IT WAS RAGGED/BROKE SO THEY HAD TO SLICE THE WALL WITH A KNIFE/SCISSOR TO BE ABLE TO REMOVE THE SHEATH AND COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099412 ↗
• MalfunctionMay 21, 2025Separation Failure; Separation Failure

  THE ACCOUNT ALLEGES THE PRELUDE SNAP IS NOT PEELING APART CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061268 ↗
• MalfunctionMay 2, 2025Material Twisted/Bent; Packaging Problem

  THE TIP OF THE DILATOR WAS BENT IN THE PACKAGE. UNABLE TO USE SHEATH. A NEW ONE WAS OPENED AND USED WITHOUT ISSUE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949977 ↗
• MalfunctionMay 2, 2025Break; Device Damaged Prior to Use

  THE TIP OF THE SHEATH WAS BROKEN UPON OPENING THE PACKAGE. NO PATIENT HARM WAS DONE. NOTICED BY SCRUB WHILE FLUSHING SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949976 ↗
• MalfunctionSep 26, 2022Defective Device

  EARLY 90¿S FEMALE WITH HISTORY OF SICK SINUS SYNDROME. PROCEDURE: DUAL CHAMBER PERMANENT PACEMAKER IMPLANT. WHEN THE DEVICE WAS REMOVED FROM PACKAGING, THE SHEATH WAS OBSERVED TO NOT BE TAPERED AT THE TIP. UNABLE TO USE ON PATIENT. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, PRELUDE SNAP¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485010 ↗
• MalfunctionDec 15, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VENOUS PUNCTURE WHILE ATTEMPTING TO ACCESS THE VESSEL USING A NEEDLE AND GUIDEWIRE IN THE PACKAGE, THE DOCTOR NOTICED THE END OF THE WIRE HAD CURLED UP AND GOT STUCK AT THE END OF THE NEEDLE. PART OF THIS WIRE HAD BROKEN OFF AND WAS STUCK INSIDE THE PATIENTS SURROUNDING TISSUE. THE DOCTOR WAS NOT ABLE TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT, SO IT WAS LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFUL AND THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13015109 ↗