Agilis™ G408320Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734206136), received between Mar 29, 2019 and Oct 27, 2025 — classified as 1 death, 3 injuries, 3 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, K241370, K243493); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE ASPIRATING FOR BLOOD, AN AIR BUBBLE WAS OBSERVED. 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 23392592 ↗
• MalfunctionJan 9, 2024Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REFERENCE: (B)(4) DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED WITH THE INTRODUCER. THE INTRODUCER WAS REPLACED TO COMPLETE THE PROCEDURE. ALSO DURING THIS PROCEDURE, DEFLECTION ISSUES WERE NOTED WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON REMOVAL, A PHYSICAL BREAK WAS NOTED ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475946 ↗
• MalfunctionJun 5, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE DILATATOR PUNCTURED THE SHEATH. THE STYLET HAD BEEN USED AND NO ADDITIONAL PUNCTURE SITE WAS NECESSARY. THE SHEATH WAS SWAPPED OUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067171 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 3008452825-2020-00113, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9744983 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00021, 3008452825-2020-00113, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9744978 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. FOLLOWING TRANSSEPTAL PUNCTURE WITH AN SL0 SHEATH AN AGILIS WAS INSERTED. WHILE INSERTING THE AGILIS THROUGH THE TRANSSEPTAL PUNCTURE THE PERICARDIAL SEPTUM WAS INADVERTENTLY PUNCTURED. ECHOCARDIOGRAPHY CONFIRMED AN EFFUSION AND THE PROCEDURE WAS STOPPED TO MONITOR THE EFFUSION. A PERICARDIOCENTESIS WAS REQUIRED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9310256 ↗
• DeathMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 8465811 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061363, K241370, K243493. 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