Inquiry™ IBI-81105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734302982), received between Dec 19, 2018 and Feb 28, 2023 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionFeb 28, 2023Material Twisted/Bent

  CATHETER INSERTED INTO PATIENT (PT.). CATHETER FOUND TO BE BENT. REMOVED WITH NO PATIENT (PT.) HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451950 ↗
• MalfunctionOct 24, 2022Defective Device

  CATHETER STEERING SYSTEM MALFUNCTIONING WHILE IN THE BODY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657326 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2018-00505. DURING A RIGHT PULMONARY VEIN CONTRACTION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. FOLLOWING ABLATION IN THE RIGHT ATRIUM, AFTER THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM, ECHOGRAPHY WAS PERFORMED. AN EFFUSION WAS OBSERVED AND WHEN CHECKED AGAIN HAD NOT IMPROVED. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8180966 ↗