Prelude® 10884450614959Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450614959), received between Oct 18, 2023 and Oct 24, 2023 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionOct 24, 2023Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTS THE HUB OF THE DILATOR SNAPPED OFF AND THE BODY REMAINED IN PATIENT, BUT THE PHYSICIAN WAS ABLE TO CATCH AND REMOVE IT. NO PATIENT HARM WAS NOTED ON THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000172 ↗
• MalfunctionOct 18, 2023Fracture; Fracture

  THE CUSTOMER REPORTS THE HUB OF THE DILATOR SNAPPED OFF AND THE BODY REMAINED IN PATIENT, BUT THE PHYSICIAN WAS ABLE TO CATCH AND REMOVE IT. NO PATIENT HARM WAS NOTED ON THIS CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17957991 ↗
• InjuryOct 18, 2023Fracture; Fracture

  THE CUSTOMER REPORTED THAT A PATIENT WAS DISCHARGED AFTER A RADIAL CATH PROCEDURE. THE PATIENT EXPRESSED THAT THEY WERE EXPERIENCING SEVERE ARM PAIN AND THE PHYSICIAN REASSURED THEM THAT ARM PAIN WAS NORMAL POST PROCEDURE. THE PATIENT LATER PRESENTED THE ARM PAIN TO THE EMERGENCY DEPARTMENT AND IMAGING WAS DONE WHICH REVEALED A FOREIGN BODY. THE PATIENT WAS THEN TAKEN INTO THE OPERATING ROOM WHERE THE PORTION OF A PRELUDE DILATOR WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17957978 ↗