Agilis™ G408318Recalls & reported problems

Summary

The FDA's MAUDE database contains 333 adverse event reports that list this exact device (DI 05414734206112), received between Jun 15, 2018 and Sep 24, 2026 — classified as 7 injuries, 326 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (152 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 333 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884214 ↗
• MalfunctionJun 2, 2026Gas/Air Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AND AIR LEAK WAS NOTED DURING FLUSHING OF THE SIDEPORT OF THE AGILIS 8.5 FR SHEATH. THE TACTIFLEX SE CATHETER WAS INTRODUCED INTO THE AGILIS 8.5 FR SHEATH WHEN THE AIR LEAK WAS NOTED. THE AGILIS 8.5 FR SHEATH WAS REPLACED; THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359917 ↗
• MalfunctionJun 1, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED ON THE AGILIS 8.5 FR SHEATH WHEN EXCHANGING THE CATHETER. THE AGILIS 8.5 FR CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES. THE AGILIS 8.5 FR SHEATH WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349002 ↗
• MalfunctionApr 30, 2026Gas/Air Leak

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, AIR ASPIRATED FROM THE SHEATH. THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM. NEAR THE END OF THE PROCEDURE, WHEN ATTEMPTING TO PERFORM AN AIR FLUSH OF THE SHEATH, AIR WAS ASPIRATED. ASPIRATION WAS PERFORMED SEVERAL TIMES FROM THE SIDE PORT; HOWEVER, THE AIR COULD NOT BE FULLY REMOVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25039926 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, BLOOD LEAKED FROM THE SHEATH VALVE WHEN OPERATING THE ABLATION CATHETER THROUGH THE AGILIS SHEATH AND WHEN THE CATHETER WAS WITHDRAWN. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872346 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  DURING ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715899 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, BLOOD LEAKAGE WAS NOTED FROM THE HEMOSTASIS VALVE. AFTER THE CATHETER WAS INSERTED INTO THE SHEATH INTO THE LEFT ATRIUM, BLOOD LEAKAGE WAS NOTED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649778 ↗
• MalfunctionMar 6, 2026Gas/Air Leak

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE SHEATH. THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM AND THE ABLATION CATHETER WAS INTRODUCED. DURING RF DELIVERY, AIR EVACUATION WAS PERFORMED VIA THE SIDE PORT, AND AIR WAS ASPIRATED. MULTIPLE ATTEMPTS WERE MADE TO ASPIRATE THE AIR WITH NO RESOLUTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531188 ↗
• MalfunctionFeb 26, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE SHEATH. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462218 ↗
• MalfunctionFeb 24, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE SHEATH INTO THE PATIENT AND DURING THE PREPARATION PHASE BEFORE INTRODUCING THE CATHETER, AIR WAS ASPIRATED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430067 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE VALVE LEAKED BLOOD AFTER INSERTING THE INTRODUCER INTO THE PATIENT. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390211 ↗
• MalfunctionFeb 19, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM, ASPIRATION WAS PERFORMED FOR FLUSHING PRIOR TO CATHETER INSERTION, AND AIR WAS ASPIRATED. SEVERAL ATTEMPTS WERE MADE TO ASPIRATE THE AIR, BUT THE AIR COULD NOT BE FULLY REMOVED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389492 ↗
• MalfunctionFeb 19, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER THE AGILIS INTRODUCER SHEATH WAS INSERTED INTO THE PATIENT, AIR WAS ASPIRATED BEFORE CATHETER INSERTION. THE AGILIST INTRODUCER SHEATH WAS REPLACED AND THE PROCEDURE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389477 ↗
• MalfunctionFeb 17, 2026Gas/Air Leak

  DURING THE DIAGNOSTIC PROCEDURE, AIR WAS ASPIRATED FROM THE VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368824 ↗
• MalfunctionFeb 2, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM. MAPPING WAS PERFORMED USING THE NON-ABBOTT CATHETER (ORION BY BOSTON SCIENTIFIC). DURING RF DELIVERY WITH THE NON-ABBOTT CATHETER (STABLEPOINT BY BOSTON SCIENTIFIC), AIR WAS ASPIRATED FROM THE SIDE PORT OF THE SHEATH. DESPITE MULTIPLE ATTEMPTS TO ASPIRATE THE AIR, IT COULD NOT BE COMPLETELY REMOVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238066 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR ENTERED THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192232 ↗
• MalfunctionJan 15, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING AND WITHDRAWING MAPPING CATHETERS THROUGH THE INTRODUCER, INTERMITTENT AIR ASPIRATION WAS OBSERVED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080777 ↗
• MalfunctionJan 13, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053430 ↗
• MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE ABLATION CATHETER WAS INSERTED INTO THE AGILIS SHEATH AND THEN MANIPULATED, AND THE PHYSICIAN NOTICED THAT BLOOD LEAKED FROM THE VALVE OF THE AGILIS SHEATH WHEN REMOVING IT FROM THE PATIENT¿S BODY. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863393 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF A SIDEPORT TUBING DETACHMENT THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822690 ↗
• MalfunctionDec 4, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, AIR LEAKED FROM THE SHEATH. THE SHEATH WAS INSERTED INTO THE HEART AND THE DILATOR WAS REMOVED. WHEN NEGATIVE PRESSURE WAS APPLIED FOR FLUSHING, AIR WAS ASPIRATED INTO THE SYRINGE. AIR WAS ASPIRATED SEVERAL TIMES, BUT IT COULD NOT BE COMPLETELY REMOVED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720629 ↗
• MalfunctionDec 1, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE INTRODUCER. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684989 ↗
• MalfunctionNov 25, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS AN AIR LEAK FROM THE SHEATH. THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, AND WHEN FLUSHING BEFORE INSERTING THE CATHETER OR SEPTAL PUNCTURE NEEDLE, AIR WAS ASPIRATED. AIR WAS ASPIRATED MULTIPLE TIMES, BUT THE AIR COULD NOT BE COMPLETELY REMOVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645378 ↗
• MalfunctionNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE HEMOSTASIS VALVE LEAKED BLOOD. THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND WHEN THE DILATOR WAS REMOVED PRIOR TO THE INSERTION OF THE CATHETER AND SEPTAL PUNCTURE NEEDLE, BLOOD LEAKED FROM THE VALVE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605552 ↗
• MalfunctionNov 5, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT AIR WAS ASPIRATED DURING ASPIRATION WHEN THE CATHETERS WERE EXCHANGED. EVEN AFTER ASPIRATING AIR SEVERAL TIMES, AIR COULD NOT BE REMOVED COMPLETELY. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480516 ↗

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