Agilis™ G408324Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 05414734206150), received between Jun 22, 2018 and May 8, 2026 — classified as 42 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (38 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. 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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTATIC VALVE OF 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 25128972 ↗
• MalfunctionApr 21, 2026Material Puncture/Hole

  DURING THE VT PROCEDURE, A HOLE IN THE SHEATH AT THE TIP PREVENTED TRANSSEPTAL 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 24941553 ↗
• MalfunctionApr 10, 2026Gas/Air Leak

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, AIR WAS ASPIRATED FROM THE HEMOSTATIC VALVE OF 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 24844822 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, BLOOD LEAKAGE WAS NOTED FROM THE SIDE PORT OF THE SHEATH. THE BLOOD LEAK WAS MINIMAL, AND THE PROCEDURE WAS COMPLETED WITH THE SAME SHEATH WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665177 ↗
• MalfunctionFeb 23, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED WHEN REMOVING AIR IMMEDIATELY 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 24423791 ↗
• MalfunctionFeb 23, 2026Gas/Air Leak

  IT WAS NOTED THAT THE SHEATH WAS PULLING AIR. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419422 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS BLOOD BACKFLOW 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 24368760 ↗
• MalfunctionJan 30, 2026Gas/Air Leak

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, AFTER INSERTION INTO THE ACCESS SITE, WHEN THE SHEATH WAS CHECKED FOR BUBBLES, CONTINUOUS AIR INTRODUCTION WAS NOTED. THE LINES WERE CHECKED FOR PROPER CONNECTION, 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 24227359 ↗
• MalfunctionJan 20, 2026Gas/Air Leak

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, AIR ASPIRATION WAS OBSERVED DURING INSERTION VIA THE FEMORAL VEIN. DAMAGE TO THE ONE-WAY VALVE WAS SUSPECTED. 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 24123493 ↗
• MalfunctionDec 15, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, AIR WAS LEAKING FROM THE SHEATH VALVE. 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 23805236 ↗
• MalfunctionDec 4, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PVI PROCEDURE, AIR LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS EXCHANGED, AND AIR LEAK WAS NOTED AGAIN. THE SHEATH WAS EXCHANGED AGAIN, AND THE ISSUE WAS RESOLVED. THE STYLET WAS USED, AND NO ADDITIONAL PUNCTURE WAS REQUIRED TO ACCESS THE SITE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718444 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD WAS LEAKING 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 23376047 ↗
• InjuryOct 21, 2025Peeled/Delaminated; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Peeled/Delaminated; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem

  AFTER ATRIAL FIBRILLATION PROCEDURE, THE HEALTH CARE PROVIDER REMOVED THE SHEATH FROM THE PATIENT AND THERE WAS A FIBER CONTAINED IN THE SHEATH. WE PULLED IT OFF AND THE PATIENT IS STABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF RESISTANCE DURING INSERTION OF THE NEEDLE INTO THE SHEATH. IT IS THOUGHT THAT THE STYLET WAS NOT USED. THE NEEDLE WAS NOT RESHAPED. IT IS UNKNOWN WHAT COULD HAVE CAUSED THE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346918 ↗
• MalfunctionOct 18, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM. THE ADVISOR HD GRID X CATHETER WAS INSERTED THROUGH THE SHEATH AND WHILE PERFORMING AIR ASPIRATION, AIR WAS ASPIRATED. DESPITE MULTIPLE ATTEMPTS, COMPLETE AIR REMOVAL COULD NOT BE ACHIEVED. THE SHEATH WAS REPLACED WITH AN ALTERNATIVE PRODUCT, AND THE PROCEDURE WAS CONTINUED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23332066 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. DURING TRANSSEPTAL PUNCTURE THE CONTRAST AGENT WAS VISUALIZED IN THE PERICARDIUM ON X-RAY. THE PATIENT REMAINED STABLE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS MOVED TO THE RECOVERY ROOM FOR OBSERVATION IN STABLE CONDITION. NO INTERVENTION WAS NEEDED.

  Patient problems: Cardiac Perforation

  MAUDE report 22777091 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, WHEN THE ABLATION CATHETER WAS MANIPULATED IN THE SHEATH AND REMOVED FROM THE PATIENT¿S BODY, BLOOD LEAKED FROM THE SHEATH 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 22646697 ↗
• MalfunctionJul 14, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, AFTER INSERTION INTO THE PATIENT, AIR WAS ASPIRATED. IT WAS THOUGHT THE VALVE WAS NOT AIRTIGHT. 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 22502687 ↗
• MalfunctionJul 2, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PROCEDURE, THE VALVE OF THE SHEATH WAS LEAKING AIR. AN AIR BUBBLE WAS NOTICED INTO THE TUBING OF THE SHEATH AT THE BEGINNING OF THE PROCEDURE. THE SHEATH HAS BEEN CHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383812 ↗
• InjuryJul 2, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE SHEATH WAS LEAKING AIR WHICH RESULTING IN AN AIR EMBOLISM AND ST ELEVATION. AT THE START OF MAPPING, WITH THE MAPPING CATHETER IN THE SHEATH, ST ELEVATIONS APPEARED ON THE ECG. A CORONARY ANGIOGRAPHY WAS USED TO VISUALIZE THE RIGHT CORONARY ARTERY HOWEVER NOTHING WAS NOTED. THE SHEATH WAS RINSED AGAIN, A NEW MAP WAS STARTED, AND THE ST ELEVATIONS DISAPPEARED OVER TIME. WHEN MAPPING WAS FINISHED, THE MAPPING CATHETER WAS REPLACED WITH THE ABLATION CATHETER. ST ELEVATIONS APPEARED AGAIN AT THE START OF ABLATION. THE ABLATION WAS THEN STOPPED AND THE CORONARY ANGIOGRAPHY WAS REPEATED. THIS TIME THERE WERE AIR BUBBLES IN THE RIGHT CORONARY ARTERY. THE SHEATH WAS REPLACED AND THE ISSUES RESOLVED. IT IS ALLEGED THAT THE SHEATH WAS LEAKING AIR. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH NO FURTHER COMPLICATIONS.

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 22383658 ↗
• MalfunctionJun 10, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN AF PROCEDURE USING ENSITE X IN VOXEL MODE, THERE WAS AN AIR LEAK THROUGH THE SHEATH. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175819 ↗
• MalfunctionMay 22, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN EP PROCEDURE, WHEN REMOVING THE INTRODUCER AND ABLATION CATHETER TOGETHER, A PLASTIC LIKE PIECE WAS NOTED TO BE HANGING FROM THE TIP SIDE. THE CATHETER WAS REMOVED FROM THE INTRODUCER, AND PLASTIC PIECE WAS TAKEN FROM THE TIP SIDE OF AGILIS. THE WHOLE LENGTH WAS THE SAME AS AGILIS INTRODUCERS BODY. THEY EXCHANGED INTRODUCER TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073345 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION PROCEDURE, SHORTLY AFTER INSERTING THE SHEATH INTO THE RIGHT ATRIUM AND BEFORE SEPTAL PUNCTURE, 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. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518352 ↗
• MalfunctionFeb 26, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE INTRODUCER WAS INSERTED AND WHILE ATTEMPTING TO FLUSH IT FROM THE SIDEPORT, AIR WAS ASPIRATED. THE DEVICE WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. NO ADDITIONAL ACCESS PUNCTURE SITE WAS NEEDED DUE TO THE DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472258 ↗
• MalfunctionFeb 19, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AIR ENTERED FROM THE HEMOSTASIS VALVE OF THE SHEATH BODY. 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 21414242 ↗
• MalfunctionJan 29, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK OCCURRED. 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 21264170 ↗