Prelude IDeal™ 10884450317621Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884450317621), received between Apr 17, 2020 and Aug 5, 2020 — 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 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.

• InjuryAug 5, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR PROCEDURE, THE VASCULAR ACCESS SHEATH DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED RETROGRADE ARTERIAL ACCESS AND DURING A CATHETER EXCHANGE, THE PHYSICIAN NOTED THAT THE SHEATH HAD DETACHED FROM ITS HUB. THE DETACHED SHEATH CONTINUED TO MIGRATE FURTHER INTO THE PATIENT'S ARTERY WHILE STILL ON THE GUIDE WIRE. THE PHYSICIAN WAS ABLE TO THEN ADVANCE A SMALL VASCULAR BALLOON OVER THE WIRE, TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10371315 ↗
• MalfunctionJun 10, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERCUTANEOUS TRANSLUMINAL ACCESS FOR A MEDICAL PROCEDURE, THE HUB OF THE INTRODUCER DETACHED WHEN THE CLINICIAN WAS ATTEMPTING TO REMOVE THE ACCESS GUIDEWIRE AND THE INTRODUCER. THE PHYSICIAN WAS SUCCESSFUL IN RETRIEVING THE DETACHED INTRODUCER FROM THE ACCESS SHEATH AND CONTINUED TO USE THE SHEATH TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10141384 ↗
• MalfunctionApr 17, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING PERCUTANEOUS TRANSLUMINAL ACCESS FOR A CHRONIC TOTAL OCCLUSION [CTO] PROCEDURE, THE HUB OF THE 7F INTRODUCER DETACHED WHEN THE CLINICIAN WAS ATTEMPTING TO REMOVE THE ACCESS GUIDE WIRE AND THE INTRODUCER TOGETHER. THE PHYSICIAN WAS SUCCESSFUL IN RETRIEVING THE DETACHED INTRODUCER FROM THE ACCESS SHEATH AND CONTINUED TO USE THE PRIMARY ACCESS SITE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9972578 ↗