AgilisRecalls & reported problems across all models

We found 9 models of Agilis by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 955 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Sep 29, 2026 — classified as 6 deaths, 154 injuries, 795 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (347 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Agilis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 30, 2024Open, Classified

   One lot of product has dilators that are too short and will not extend outside the introducer sheath.

   Z-2348-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Agilis problems

Agilis models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Agilis™ G408318

  INTRODUCER, CATHETER
  333 reports
• Agilis™ 408310

  INTRODUCER, CATHETER
  2 deaths218 reports
• Agilis™ 408309

  INTRODUCER, CATHETER
  1 recall3 deaths166 reports
• Agilis™ G408324

  INTRODUCER, CATHETER
  120 reports
• Agilis™ G408319

  INTRODUCER, CATHETER
  97 reports
• Agilis™ G408321

  INTRODUCER, CATHETER
  10 reports
• Agilis™ G408320

  INTRODUCER, CATHETER
  1 death7 reports
• Agilis™ G402049

  INTRODUCER, CATHETER
  3 reports
• Agilis™ G408332

  Introducer, catheter
  1 report

Recent Agilis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  This report is to advise of a sideport detachment found during analysis. During the AF procedure, it was noted that the tip of the introducer was torn. The introducer was exchanged, and the procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927379 ↗
• MalfunctionSep 29, 2026Material Separation

  This report is to advise of a sideport detachment found during analysis.During device preparation for an AF procedure, the tip of the sheath was noted to be torn. The device was exchanged and the procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927309 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  During an atrial fibrillation procedure, blood was noted to be leaking from the Agilis 8.5F sheath after removing the sheath from the patient. The sheath was exchanged and the procedure was completed with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915355 ↗
• MalfunctionSep 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884214 ↗
• InjurySep 24, 2026Difficult to Insert

  During the atrial fibrillation procedure, it was noted that the sheath was obstructed when inserting the catheter. A second venipuncture was preformed and the sheath was replaced, and the procedure was completed without adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883280 ↗
• MalfunctionAug 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380046 ↗
• MalfunctionAug 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380007 ↗
• MalfunctionAug 6, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150718 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  During the PVC procedure, the coronary sinus was perforated. Mapping was performed with the Agilis sheath and a decapolar catheter. The decapolar catheter was slipped back into the Agilis and then the physician believes that the Agilis perforated the coronary sinus. A venogram showed contrast in the pericardial space. The procedure was abandoned and protamine administered. No intervention was performed. The patient remained hemodynamically stable and is recovering. There were no product performance issues.

  Patient problems: Cardiac Perforation

  MAUDE report 50147046 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 28, 2026Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS. DURING AN SVT PROCEDURE, IT WAS REPORTED THAT FOLLOWING TRANSSEPTAL ACCESS, THE SHEATH TIP APPEARED DEFORMED ON FLUOROSCOPY. THE SHEATH HAD BEEN USED TO OBTAIN TRANSSEPTAL ACCESS AND THE ACCESS WAS NOTED TO BE DIFFICULT, REQUIRING QUITE A BIT OF FORCE TO TRANSITION THE SHEATH TIP INTO THE LEFT ATRIUM. THE DILATOR WAS REMOVED AND THE RF ABLATION CATHETER WAS ADVANCED INTO THE SHEATH, HOWEVER, THE PHYSICIAN WAS UNABLE TO GET THE CATHETER THROUGH THE SHEATH TIP EASILY. FLUOROSCOPY REVEALED A DEFECT NEAR THE TIP. THE SHEATH WAS EXCHANGED OVER A WIRE. THE ISSUE WAS RESOLVED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315286 ↗
• MalfunctionMay 25, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE ABLATION CATHETER WAS INSERTED INTO THE SHEATH, EXCESS BUBBLES WERE REPORTED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272619 ↗
• MalfunctionMay 20, 2026Gas/Air Leak

  DURING A PVI PROCEDURE, BEFORE TRANSSEPTAL PUNCTURE, AIR WAS ASPIRATED. THE SHEATH WAS REPLACED BUT THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED AGAIN, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231145 ↗

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