Inquiry™ D087023Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734311434), received between Apr 19, 2019 and Aug 16, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION (AF) PROCEDURE, BLOOD WAS DRIPPING OUT OF THE CATHETER HANDLE. THE CATHETER WAS REMOVED AND IT WAS NOTED THAT THE BRAIDING AT THE DISTAL END OF THE CATHETER WAS DAMAGED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324147 ↗
• MalfunctionSep 21, 2020Break; Break

  DURING ATRIAL FIBRILLATION ABLATION PROCEDURE, THE ELECTRODE OF THE CATHETER FRACTURED WITHIN THE INTRODUCER SHEATH. THE CATHETER AND SHEATH WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560439 ↗
• MalfunctionAug 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A TORN LOOP, EXPOSING THE CONDUCTOR WIRES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366879 ↗
• MalfunctionJun 9, 2020Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  DURING THE PROCEDURE, THE DIAGNOSTIC CATHETER BECAME STUCK IN THE SIDE HOLE OF THE INTRODUCER DURING INSERTION. DURING REMOVAL, THE CATHETER WAS BENT WITH EXPOSED INTERNAL COMPONENTS. THE INTRODUCER AND CATHETER WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133421 ↗
• MalfunctionJun 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TIP ELECTRODE DETACHED FROM THE CATHETER. THE CATHETER WAS DIFFICULT TO INSERT AND BECAME LODGED WITHIN THE INTRODUCER. UPON REMOVAL OF THE CATHETER FROM THE INTRODUCER, THE ELECTRODE WAS NOTED TO BE DETACHED. THE CATHETER AND INTRODUCER WERE EXCHANGED AND THE PROCEDURE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118338 ↗
• MalfunctionSep 4, 2019Material Separation; Material Separation

  DURING A PROCEDURE, WHEN THE CATHETER WAS BEING REMOVED FROM THE INTRODUCER, THE CATHETER TIP BECAME DETACHED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8961438 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED UPON RECEIPT OF THE DEVICE REVEALING A FRACTURED AND DETACHED ELECTRODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531027 ↗