Advisor™ D-AVSE-D10-F15Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067024800), received between Feb 1, 2019 and Feb 11, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356744 ↗
• MalfunctionJul 26, 2024Fracture; Material Deformation; Fracture; Material Deformation

  THIS REPORT IS TO ADVISE OF A FRACTURE AND DISPLACED ELECTRODES FOUND ON THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840967 ↗
• MalfunctionFeb 26, 2024Signal Artifact/Noise; Expiration Date Error; Signal Artifact/Noise; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED ON 3/28/24 CONFIRMED THE CORRECT LOT NUMBER IS 8622315 AND THE CORRECT EVENT DATE WAS OCTOBER 21, 2023. THE EXPIRATION DATE OF THIS LOT WAS JANUARY 31, 2024 AND WAS THEREFORE NOT EXPIRED AT THE TIME OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778608 ↗
• MalfunctionFeb 16, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF CATHETER FRACTURES NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722192 ↗
• MalfunctionFeb 1, 2024Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625574 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. AFTER LEFT PULMONARY VEIN ISOLATION THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAPHY CONFIRMED A PERICARDIAL EFFUSION AROUND THE RIGHT AND LEFT HEART CAVITIES. THE PROCEDURE WAS STOPPED, AND THE PERICARDIAL EFFUSION WAS DRAINED BY PERCUTANEOUS PUNCTURE, WHICH STABILIZED THE PATIENT. IT IS UNKNOWN WHAT CAUSED THIS PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 18547465 ↗
• MalfunctionDec 23, 2022Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, ONCE POSITIONED ON THE SEPTUM TO PERFORM THE TRANSSEPTAL PUNCTURE, A FRACTURE WAS NOTED ON THE SHAFT OF THE DEVICE. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043370 ↗
• MalfunctionApr 5, 2022Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS TO ADVISE OF A DISPLACED AND FLARED ELECTRODE NOTED DURING DEVICE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013925 ↗
• MalfunctionAug 4, 2021Difficult to Insert; Difficult to Insert

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DISPLACED ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274110 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, AFTER MAPPING THE PAROXYSMAL ATRIAL FIBRILLATION IN THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ULTRASOUND. THE ISOLATION OF THE FOUR PULMONARY VEINS WAS CARRIED OUT AND THEN THE PATIENT WAS STABILIZED BY CONDUCTING A PERICARDIOCENTESIS. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 12188533 ↗
• InjuryJun 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AFTER CONDUCTING THE TRANSSEPTAL PUNCTURE, THE PHYSICIAN SUSPECTED THERE WAS A CLOT ON THE MAPPING CATHETER WHEN USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY. THE PROCEDURE WAS CONTINUED WITH ONLY USING THE ABLATION CATHETER FOR MAPPING AND ABLATION AND THE MAPPING CATHETER WAS NOT MOVED. A BOLUS OF HEPARIN WAS DELIVERED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. BOTH THE ABLATION AND MAPPING CATHETER WERE REMOVED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND NO CLOTS WERE OBSERVED. THE PHYSICIAN SUSPECTED THE CLOT WAS FROM THE RIGHT ATRIUM AND WENT INTO THE LEFT ATRIUM WHEN THE TRANSSEPTAL PUNCTURE WAS CONDUCTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11929162 ↗
• MalfunctionAug 21, 2020Material Rupture; Material Rupture

  DURING THE PROCEDURE, ELECTRODE ONE RUPTURED WHILE BEING REMOVED FROM THE INTRODUCER. ANOTHER CATHETER WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437136 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A SEPARATED ELECTRODE ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296927 ↗