Prelude® Short Sheath 10884450015329Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450015329), received between Apr 6, 2022 and Dec 12, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING A FISTULAGRAM/ANGIO WHEN THE MD REMOVED THE SHORT SHEATH OUT AT COMPLETION, THE BLACK TIP WAS BROKEN OFF INSIDE OF THE PATIENT. THE MD HAD TO THEN ATTEMPT TO RETRIEVE THE TIP AND WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314755 ↗
• InjurySep 30, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT AFTER THE PHYSICIAN REMOVED THE SHEATH, IT WAS NOTED THAT THE SHEATHS BLACK MARKER TIP HAD DETACHED. THE CLINICAL STAFF LOOKED FOR THE FOREIGN BODY UNDER FLUOROSCOPY AND WAS ABLE TO SUCCESSFULLY IDENTIFY THE MARKER TIP WITHIN THE PATIENT'S ARTERIOVENOUS FISTULA. THE PHYSICIAN DEPLOYED A COVERED STENT TO SUCCESSFULLY PIN THE FOREIGN BODY IN PLACE, PREVENTING FOREIGN BODY MIGRATION. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15510034 ↗
• MalfunctionApr 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING VASCULAR ACCESS FOR A ROUTINE AV FISTULAGRAM PROCEDURE, THE HUB OF THE 7F SHEATH INTRODUCER/DILATOR DETACHED WHILE ATTEMPTING TO ACQUIRE VASCULAR ACCESS VIA "SELDINGER TECHNIQUE". NO PATIENT INJURY TO REPORT. THE SHEATH WAS EXCHANGED FOR A NEW ONE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024779 ↗