Inquiry™ IBI-81402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734304122), received between Jun 18, 2024 and Feb 17, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  AT THE BEGINNING OF THE PROCEDURE, WHILE PASSING THE CATHETER NEAR THE HIS BUNDLE, A BUNDLE BRANCH BLOCK WITH ASYSTOLE WAS TRIGGERED. STIMULATION WAS PERFORMED WITH THE NON-ABBOTT (EPTRACER BY SCHWARZER CARDIOTEK) UNTIL A TEMPORARY PACEMAKER WAS INSERTED. THE PATIENT REMAINS STABLE WITH PLANS TO PLACE A PERMANENT PACEMAKER. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. THE CAUSE OF THE BLOCK WAS DUE TO A MANEUVER PERFORMED BY THE PHYSICIAN.

  Patient problems: Heart Block

  MAUDE report 24366853 ↗
• InjuryJun 18, 2025Difficult to Insert; Difficult to Insert

  DURING A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION, A PERICARDIAL EFFUSION OCCURRED WITH NO INTERVENTION NEEDED. CARDIAC MOTION WAS RESTRICTED ON FLUOROSCOPY AND THE PATIENT EXPERIENCED MINOR CHEST PAIN. WHILE USING THE ICE CATHETER, AN EFFUSION WAS NOTED; TEE CONFIRMED A 0.5CM EFFUSION. NO INTERVENTION WAS REQUIRED; THE PROCEDURE WAS STOPPED AND THE PATIENT WAS OBSERVED OVERNIGHT. IT IS SUSPECTED THAT THE PERFORATION WAS DUE TO DIFFICULT RV PLACEMENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22283747 ↗
• MalfunctionJun 18, 2024Fracture; Fracture

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER WAS POSITIONED IN THE CORRESPONDING HEART AREA WITHOUT DIFFICULTY. AT THE TIME OF WITHDRAWAL, A FRACTURE WAS NOTED ON THE CATHETER. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564317 ↗