Prelude IDeal™ 10884450523077Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884450523077), received between Nov 7, 2022 and Nov 8, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2022Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER ALLEGES THAT DURING A LEFT HEART CATH [LHC] PROCEDURE, THE TIP OF THE ACCESS WIRE DETACHED WITHIN THE PATIENTS ARTERY. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY WITH A VASCULAR SNARE DEVICE LIBERATING THE VESSEL. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756749 ↗
• InjuryNov 7, 2022Break

  70Y/O MALE SCHEDULED FOR LHC (LEFT HEART CATHETERIZATION) DUE TO ABNORMAL FINDINGS DIAGNOSTIC IMAGING AND CORONARY CIRCULATION. HX (HISTORY OF CORONARY ARTERY DISEASE) OF CAD, HF (HEART FAILURE), HTN (HYPERTENSION), HYPERLIPIDEMIA, SSS (SICK SINUS SYNDROME), S/P PACEMAKER IMPLANT. ON (B)(6) 2022 S/P LHC: FINDINGS NON OBSTRUCTIVE CORONARY ARTERY DISEASE, NORMAL EF (EJECTION FRACTION) 55% AND LVEDP (LEFT VENTRICULAR END DIASTOLIC PRESSURE). TX: MEDICAL MANAGEMENT LHC REPORT: DR. : "THE TIP OF THE ACCESS WIRE BROKE AND I DECIDED TO PERFORM FEMORAL APPROACH. WE WILL PERFORM ULTRASOUND OF THE RIGHT FOREARM TO EVALUATE FOR PATENCY OF ULNAR AND RADIAL ARTERIES." PATIENT IN CATH LAB HOLDING ROOM, S/P ULTRASOUND OF RIGHT UPPER EXTREMITY ARTERIAL DOPPLER: RESULTS: PATENT RADIAL AND ULNAR ARTERIES AS CLINICALLY QUESTIONED. DR. AWARE, AND WILL DISCHARGE PATIENT. DR. SPOKE TO PATIENT AND FAMILY ON THE PHONE, RELAYED US (ULTRASONOGRAM)RESULTS AND WILL FOLLOW UP PATIENT IN 1 WEEK. GAVE INSTRUCTIONS TO PATIENT IF SEVERE PAIN AND LOSS OF SENSATION AND COLOR CHANGED ON THE HANDS TO IMMEDIATELY GO TO NEAREST EMERGENCY ROOM. MEDICAL DIRECTOR OF CATH LAB WAS NOTIFIED RECOMMEND US (ULTRASONOGRAM) AND IF

  Patient problems: Pain; Skin Discoloration

  MAUDE report 15754803 ↗