Agilis™ 408309Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 05414734206099), received between Jun 27, 2018 and Sep 29, 2026 — classified as 3 deaths, 30 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (52 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 166 reports, 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 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 ↗
• 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 ↗
• MalfunctionMar 31, 2026Material Separation

  THIS REPORT IS TO ADVISE OF DETACHED SIDEPORT TUBING THAT WAS NOTED DURING ANALYSIS. DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE PACKAGE OF THE SHEATH WAS OPENED, AND WHEN ATTEMPTING TO FLUSH THE SHEATH FROM THE SIDE PORT BEFORE INSERTION INTO THE PATIENT, RESISTANCE WAS NOTED, AND SALINE DID NOT FLOW INTO THE SIDE PORT TUBE. EVEN WHEN APPLYING CONSIDERABLE PRESSURE TO FLUSH IT, SALINE ONLY ENTERED THE SIDE PORT TUBE INTERMITTENTLY. 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 24745042 ↗
• MalfunctionFeb 26, 2026Material Separation

  DURING PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, UPON OPENING THE PACKAGING, IT WAS NOTED THAT THE SIDEPORT TUBING WAS DISCONNECTED FROM THE 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 24465100 ↗
• MalfunctionFeb 19, 2026Gas/Air Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AIR LEAKED FROM THE SHEATH. 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 24389689 ↗
• InjuryJan 27, 2026Material Frayed; Difficult to Insert

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE SHEATH TIP WAS FRAYED, WHICH MADE IT DIFFICULT TO INSERT. THE SHEATH WAS EXCHANGED, HOWEVER AN ADDITIONAL PUNCTURE WAS REQUIRED DUE TO THE SHEATH ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191253 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  DURING AN AF PROCEDURE, A BLOOD LEAK WAS NOTED. THE AGILIS NXT 8.5F SHEATH WAS INTRODUCED WITHOUT COMPLICATIONS. THE PHYSICIAN PREPARED EVERYTHING FOR THE TRANSSEPTAL PUNCTURE. AFTER THE TRANSSEPTAL PUNCTURE, IT WAS NOTED THAT BLOOD CAME OUT OF THE DILATOR FROM THE AGILIS NXT 8.5F SHEATH. TO RESOLVE, THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23964738 ↗
• MalfunctionDec 29, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE SHEATH INTO THE LEFT ATRIUM AND APPLYING NEGATIVE PRESSURE FOR FLUSHING PRIOR TO CATHETER INSERTION, AIR WAS ASPIRATED INTO THE SYRINGE. 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 23911635 ↗
• MalfunctionDec 17, 2025Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE INSERTION AID OF THE DILATOR BROKE OFF WHILE THE SHEATH WAS IN THE PATIENT. ALL COMPONENTS OF THE SHEATH WERE ABLE TO BE WITHDRAWN 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 23824987 ↗
• MalfunctionNov 17, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS AN AIR LEAK FORM THE SHEATH. AFTER PATIENT CONTACT, IT WAS NOTED THAT THE SHEATH WAS PULLING BACK AIR UPON FLUSHING. 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 23575574 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS A BLOOD LEAK FROM THE HEMOSTATIC 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 23476065 ↗
• MalfunctionNov 5, 2025Fracture; Material Separation; Fracture; Material Separation

  THE DEVICE WAS RECEIVED FOR EVALUATION. THIS FOLLOW UP REPORT INCLUDES AN UPDATED INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475643 ↗
• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE AGILIS INTRODUCER INTO THE BODY AND REMOVING THE DILATOR, THE ADVISOR HD GRID CATHETER WAS ADVANCED. WHEN ATTEMPTING TO ASPIRATE AIR, AIR WAS CONTINUOUSLY ASPIRATED AND DID NOT STOP. 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 23458548 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTION OF THE SHEATH INTO THE VESSEL, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTASIS VALVE WHEN ATTEMPTING TO FLUSH THE INSIDE 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 23404080 ↗
• MalfunctionSep 18, 2025Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PERFORATION IN THE SHEATH FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087929 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE FLUSHING PORT OF THE SHEATH BROKE OFF. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949030 ↗
• MalfunctionAug 21, 2025Component Misassembled; Component Misassembled

  DURING DEVICE PREPARATION FOR THE AV NODE ABLATION PROCEDURE, IT WAS NOTED THAT THE DILATOR DID NOT FULLY ADVANCE TO THE END OF THE SHEATH. THE DILATOR WAS REMOVED FROM THE SHEATH AND PUT NEXT THE SHEATH, WHERE IT WAS NOTED THE DILATOR WAS SHORTER THAN THE SHEATH. THE DEVICE WAS EXCHANGED, AND THE NEW AGILIS WAS SUCCESSFULLY FLUSHED AND PREPARED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862384 ↗
• MalfunctionAug 13, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, OPTICAL AND STEERING ISSUES OCCURRED CAUSING A DELAY. THE MAPPING FOR THE AT SOURCE WAS FIRST DONE WITH THE ADVISOR HD GRID CATHETER AND THEN ABLATION WAS DONE WITH THE TACTIFLEX CATHETER ON THE RA FREE WALL AT AROUND 8 O'CLOCK WITH AN AGILIS SHEATH. THE TACHYCARDIA SUBSIDED BUT THEN RECOVERED. THE TACTIFLEX CATHETER WAS SWAPPED WITH THE ADVISOR HD GRID CATHETER AGAIN FOR RE-MAPPING, AND THEN THE TACTIFLEX WAS REINSERTED. WITH THE TACTIFLEX INSERTED, WHEN TRYING TO ROTATE TO A PARTICULAR CURVE, A SNAP WAS FELT, AND THE AGILIS SHEATH WOULD NOT DEFLECT BI-DIRECTIONALLY ANYMORE. IN ADDITION, THE FORCE WAS NOT DISPLAYED AND SHOWED AS "---" ON THE PANEL ON ENSITE X. THE AGILIS WAS REPLACED. THE ABLATION CATHETER WAS RESEATED AND THE TACTISYS WAS RESTARTED WITH NO RESOLUTION. THE TACTIFLEX WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792818 ↗
• MalfunctionJul 30, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS FOUND TO HAVE A BENT VALVE AFTER INSERTION IN THE PATIENT AND WAS DRAWING 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 22668432 ↗
• MalfunctionJul 23, 2025Fracture; Material Frayed; Fracture; Material Frayed

  THIS REPORT IS TO ADVISE OF A FRACTURED GUIDEWIRE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575407 ↗
• MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER TRANSSEPTAL PUNCTURE, BLOOD LEAKED OUT OF THE INTRODUCER. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501154 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE INTRODUCER WAS LEAKING BLOOD AND AIR. 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 22437478 ↗
• MalfunctionJun 24, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK WAS NOTED IN THE SHEATH. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319900 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE AIRLOCK WAS CHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183779 ↗