Agilis™ G402049Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067000255), received between Apr 25, 2023 and Jun 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K061363); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ARRHYTHMIA IN AN ARTICLE TITLED, "CLINICAL INSIGHTS INTO THE ROLE OF BEPRIDIL IN RECURRENCE PREVENTION AFTER ABLATION OF PERSISTENT ATRIAL FIBRILLATION"; MOYURU HIRATA MD1, 2025;41:E70083, HTTPS://DOI.ORG/10.1002/JOA3.70083. THIS RETROSPECTIVE STUDY INCLUDED 232 CONSECUTIVE PERAF PATIENTS WHO UNDERWENT AF ABLATION BETWEEN 2014 AND 2019. AMONG THEM, 162 RECEIVED BEPRIDIL FOR 3 MONTHS POST-ABLATION (BEPRIDIL GROUP), WHILE 70 RECEIVED NO ANTIARRHYTHMIC DRUGS (NO-AADS GROUP). BASELINE CHARACTERISTICS, PROCEDURAL DETAILS, AND OUTCOMES WERE COMPARED. KAPLAN¿MEIER ANALYSIS AND COX REGRESSION MODELS WERE USED TO EVALUATE AF/ATRIAL TACHYCARDIA (AT) RECURRENCE, WITH BEPRIDIL USE TREATED AS A TIME-DEPENDENT COVARIABLE. THERE WAS 1 EVENT OF PSEUDOANEURYSM.

  Patient problems: Pseudoaneurysm

  MAUDE report 22216677 ↗
• MalfunctionMay 22, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN EPICARDIAL VENTRICULAR TACHYCARDIA PROCEDURE, AN AIR LEAK OCCURRED IN THE SHEATH. WHEN THE SHEATH WAS ATTEMPTED TO BE FLUSHED, IT WAS NOTED THAT THE TUBING WAS CLOGGED, AND BUBBLES STARTED TO FORM INSIDE THE SHEATH. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373974 ↗
• MalfunctionApr 25, 2023Gas/Air Leak; Gas/Air Leak

  DURING AN EPICARDIAL VENTRICULAR TACHYCARDIA PROCEDURE, AN AIR LEAK WAS NOTED. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON GAINING EPICARDIAL ACCESS, THE AGILIS INTRODUCER WAS INSERTED INTO THE EPICARDIAL SPACE AND WHILE ATTEMPTING TO FLUSH, AIR WAS DRAWN BACK THROUGH THE HEMOSTATIC VALVE AND INTO THE FLUSH SYRINGE. THE SHEATH WAS REPLACED AND SUCCESSFULLY USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809686 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061363. One submission often covers many models, so check the product and lot details in each record.

• Z-2348-2024 · Apr 30, 2024 · Open, Classified
  St. Jude Medical Agilis NxT Steerable Introducer, REF 408309