Agilis™ G408319Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 05414734206129), received between Jun 27, 2018 and Aug 6, 2026 — classified as 4 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (46 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 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150718 ↗
• MalfunctionJun 16, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED AFTER THE AGILIS 8.5 FR SHEATH WAS INSERTED INTO THE PATIENT. WHILE FLUSHING THE AGILIS 8.5 FR SHEATH, AIR WAS ASPIRATED THROUGH THE HEMOSTASIS VALVE. THE AGILIS 8.5 FR SHEATH WAS EXCHANGED; THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524091 ↗
• MalfunctionMar 23, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM AND PRIOR TO CATHETER INSERTION, ASPIRATION WAS PERFORMED THROUGH THE SIDE PORT, AND AIR WAS ASPIRATED. DESPITE MULTIPLE ATTEMPTS TO ASPIRATE THE AIR THROUGH THE SIDE PORT, IT COULD NOT BE FULLY REMOVED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667659 ↗
• MalfunctionMar 6, 2026Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR LEAK WAS DETECTED FOLLOWING AN ADVISOR HD GRID CATHETER ADVANCEMENT INTO THE AGILIS 8.5F SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532827 ↗
• MalfunctionMar 6, 2026Gas/Air Leak

  DURING AN AF PROCEDURE, A FEELING LIKE AIR BEING DRAWN IN WAS NOTED WHEN ASPIRATING THE SHEATH. 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 24532578 ↗
• MalfunctionMar 2, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED THROUGH THE SIDE PORT OF THE SHEATH. MULTIPLE ATTEMPTS WERE MADE TO ASPIRATE THE AIR WITHOUT SUCCESS. 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 24482831 ↗
• MalfunctionDec 16, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE AIR COULD NOT BE COMPLETELY REMOVED WHEN THE NON-ABBOTT CATHETER (STABLEPOINT) WAS INSERTED WHILE IN THE LEFT ATRIUM. AIR WAS ABLE TO BE REMOVED, BUT MULTIPLE ATTEMPTS WERE MADE TO ASPIRATE THE AIR, AND 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 23824572 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN AF PROCEDURE, IMMEDIATELY AFTER INSERTING THE SHEATH INTO THE PATIENT (PRIOR TO SEPTAL PUNCTURE AND CATHETER INSERTION, WITH THE DILATOR AND GUIDEWIRE ALREADY INSERTED), BLOOD LEAKAGE WAS OBSERVED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714772 ↗
• MalfunctionNov 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, AND BEFORE THE CATHETER OR TRANSEPTAL NEEDLE INSERTION, BLOOD LEAKED 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 23627664 ↗
• MalfunctionNov 11, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE SHEATH WHEN INSERTING THE CATHETER. 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 23526612 ↗
• MalfunctionNov 10, 2025Gas/Air Leak; Gas/Air Leak

  AIR WAS ASPIRATED DURING AN ATRIAL FIBRILLATION PROCEDURE. FLUSHING WAS POSSIBLE WITHOUT ANY ISSUES BEFORE INSERTING THE SHEATH INTO THE PATIENT. AFTER INSERTING THE SHEATH INTO THE HEART FOLLOWED BY THE NON-ABBOTT CATHETER (ACUNAV) AND TACIFLEX SE CATHETER, THE INFUSION PUMP WAS CONNECTED TO THE SHEATH AND THE IRRIGATION WAS STARTED AT A RATE OF 20 ML/H. AT THAT TIME, THE OCCLUSION ALERT SOUNDED AND AIR WAS ASPIRATED FROM THE THREE-WAY STOPCOCK. THE ISSUE WAS CHECKED, BUT THE OCCLUSION ALERT COULD NOT BE CLEARED. THE SHEATH WAS REPLACED WITH A NON-ABBOTT STEERABLE SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511235 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS OBSERVED AFTER THE SHEATH WAS INSERTED. SEVERAL FLUSHING ATTEMPTS WERE MADE, BUT THE ISSUE PERSISTED. 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 23450861 ↗
• MalfunctionOct 31, 2025Gas/Air Leak; Gas/Air Leak

  DURING A DIAGNOSTIC PROCEDURE, AIR WAS ASPIRATED. 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 23441373 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE WITH THE NON-ABBOTT 3D SYSTEM (CARTO BY BIOSENSE WEBSTER), THE AGILIS WAS INSERTED INTO THE PATIENT AND WHILE PERFORMING THE PROCEDURE, THE HANDLE DETACHED FROM THE SHAFT OF THE SHEATH. THE SHEATH SHAFT REMAINED INTACT. IT WAS UNKNOWN WHICH DEVICE INSERTED INTO THE AGILIS AT THAT TIME. 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 23416818 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE HEART, AND THE MAPPING CATHETER WAS INSERTED INTO THE SHEATH. WHILE MAPPING, BLOOD LEAKED 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 23000726 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE HEART. WHEN THE ADVISOR HD GRID CATHETER WAS INSERTED INTO THE SHEATH AND FLUSHING WAS ATTEMPTED, AIR WAS ASPIRATED AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR AND THE ADVISOR HD GRID CATHETER. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899845 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BUBBLES ENTERED THE SHEATH IMMEDIATELY AFTER CATHETER INSERTION. THE DILATOR AND GUIDEWIRE HAD ALREADY BEEN INSERTED, AND THE CATHETER USED WAS THE NON ABBOTT CATHETER FROM BIOSENSE WEBSTER. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER. NO ABNORMAL RESISTANCE WAS NOTED WHEN INSERTING THE CATHETER, DILATOR, OR OTHER DEVICES INTO THE SHEATH, AND NO AIR MOVEMENT INTO THE PATIENT WAS OBSERVED. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899366 ↗
• MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER AFTER INSERTION 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 22350432 ↗
• MalfunctionJun 20, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, AN AIR LEAK WAS NOTED WHEN REMOVING AIR FROM THE SHEATH. THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM; THE ADVISOR HD GRID CATHETER AND ADVISOR FL CATHETER WERE INSERTED INTO THE SHEATH AND MAPPING WAS PERFORMED. DURING THE MIDDLE OF THE PROCEDURE IN WHICH THE TACTIFLEX SE CATHETER WAS INSERTED AND RF DELIVERY WAS BEING PERFORMED, A SMALL AMOUNT OF AIR WAS ASPIRATED INTO THE SYRINGE WHEN REMOVING AIR. 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 22298649 ↗
• MalfunctionJun 19, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED IN THE SHEATH. THE DILATOR WAS INSERTED INTO THE SHEATH AND PUNCTURE WAS PERFORMED. THE INTRODUCER WAS INSERTED INTO THE LEFT ATRIUM, AND WHEN ATTEMPTING TO INSERT THE HDG CATHETER, AIR WAS ASPIRATED. 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 22293019 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FOLLOWING INSERTION INTO THE RIGHT ATRIUM. THIS OCCURRED AFTER REMOVAL OF THE DILATOR, PRIOR TO CATHETER INSERTION AND TRANSEPTAL PUNCTURE. 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 22161233 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THERE WERE NO ISSUES DURING DEVICE PREPARATION AND THE BEGINNING OF THE PROCEDURE. 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 22075660 ↗
• MalfunctionMay 14, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER PUNCTURING THE FEMORAL VEIN AND INSERTING THE SHEATH, AIR WAS ASPIRATED WHEN REMOVING AIR FROM THE SIDE PORT. AIR COULD NOT BE COMPLETELY REMOVED BEFORE INSERTING THE CATHETER INTO THE SHEATH. 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 22019656 ↗
• MalfunctionMay 9, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. BEFORE CATHETER INSERTION AND SEPTAL PUNCTURE, AIR WAS ASPIRATED FROM THE SIDE PORT. DESPITE SEVERAL ATTEMPTS, 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 21991098 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER THE PUNCTURE THE SHEATH WAS INSERTED, BUT 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 21975927 ↗

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