Inquiry™ IBI-81403Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734304139), received between Dec 17, 2025 and Dec 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 17, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE CURVATURE OF THE CATHETER WAS UNUSUAL RESULTING IN A DELAY. THE CATHETER WAS EXCHANGED HOWEVER THE SAME ISSUE OCCURRED WITH THE NEW CATHETER. THE CATHETER WAS EXCHANGED AGAIN TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825054 ↗
• MalfunctionDec 17, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE CURVATURE OF THE CATHETER WAS UNUSUAL RESULTING IN A DELAY. THE CATHETER WAS EXCHANGED HOWEVER THE SAME ISSUE OCCURRED WITH THE NEW CATHETER. THE CATHETER WAS EXCHANGED AGAIN TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825053 ↗