Prelude IDeal™ 10884450317485Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884450317485), received between Oct 25, 2019 and Apr 9, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERCUTANEOUS TRANSLUMINAL ASSESS FOR A MEDICAL PROCEDURE, THE HUB OF THE INTRODUCER DETACHED WHEN THE CLINICIAN WAS ATTEMPTING TO REMOVE THE ACCESS GUIDEWIRE AND THE INTRODUCER. NO PATIENT INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9945995 ↗
• MalfunctionMar 12, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING VASCULAR ACCESS THE INTRODUCER HUB DETACHED. THE SHEATH WAS EXCHANGED FOR THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826398 ↗
• MalfunctionMar 12, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING VASCULAR ACCESS THE INTRODUCER HUB DETACHED. THE SHAFT OF THE INTRODUCER WAS SUCCESSFULLY RETRIEVED WITH A PAIR OF FORCEPS AND THE SHEATH WAS USED FOR THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826395 ↗
• MalfunctionOct 25, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE DILATOR WAS UNABLE TO BE WITHDRAWN FROM THE SHEATH AS THE HUB HAD BEEN BROKEN OFF INSIDE THE SHEATH. NEW UNIT WAS USED TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9242436 ↗