Prelude® 10884450331368Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450331368), received between Feb 8, 2022 and Oct 6, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 16, 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.

• InjuryOct 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT AFTER INSERTION INTO THE VESSEL, THE SHEATH BROKE. THE PHYSICIAN PERFORMED AN ADDITIONAL PROCEDURE TO REMOVE THE PIECES OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554024 ↗
• InjuryMay 11, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE WHILE REMOVING THE DEVICE THE PATIENT VESSEL EXPERIENCED "RADIAL SPASM" PREVENTING REMOVAL OF THE SHEATH. THE SHEATH BROKE INTO 2 PIECES, WITH ONE PIECE OF THE DEVICE REMAINING WITHIN THE PATIENT'S VASCULAR SYSTEM AND LATER REMOVED WITH A VASCULAR SNARE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366342 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER PLACING A NEEDLE IN THE RIGHT RADIAL ARTERY, A 0.018 WIRE WAS PLACED IN THE SHEATH AND ADVANCED INTO THE RIGHT RADIAL ARTERY. THE PHYSICIAN EXPERIENCED SOME DIFFICULTY ADVANCING THE WIRE AND THE ARTERY SPASMED. MEDICATION WAS ADMINISTERED. UPON REMOVING THE WIRE, IT WAS DISCOVERED THAT THE TIP HAD DETACHED. X-RAY CONFIRMED THE WIRE TIP IN THE RADIAL ARTERY. A VASCULAR SURGEON WAS CONSULTED FOR FURTHER TREATMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13485690 ↗