Prelude® Short Sheath 10884450015312Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450015312), received between Jun 9, 2021 and Jun 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE RADIOPAQUE MARKER BAND OF THE SHEATH DETACHED WITHIN THE PATIENT. VASCULAR ACCESS WAS ACHIEVED VIA SELDINGER TECHNIQUE, AND AN 035 GUIDEWIRE WAS USED TO EXCHANGE FOR A 6F SHEATH. A 6X4 PTA BALLOON WAS ADVANCED AND POSITIONED WITHIN THE VASCULATURE BUT WAS NOT INFLATED. THE FOREIGN BODY WAS OBSERVED UNDER FLUOROSCOPY MIGRATING AWAY FROM THE SHEATH. ARTERIAL AND VENOUS PRESSURE WAS QUICKLY HELD TO PREVENT MIGRATION OF THE FOREIGN BODY INTO THE PULMONARY ARTERY OR ARTERIAL SYSTEM. THE PHYSICIAN WAS SUCCESSFUL IN PERFORMING A CUTDOWN AND SUCCESSFULLY REMOVING THE FOREIGN BODY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO ADDITION CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972051 ↗