Agilis™ 408310Recalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 05414734206105), received between Jun 25, 2018 and Sep 29, 2026 — classified as 2 deaths, 64 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (62 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 218 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 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 25230968 ↗
• MalfunctionMay 6, 2026Gas/Air Leak

  DURING THE PVI PROCEDURE, AIR LEAKED FROM THE SHEATH DURING THE TRANSSEPTAL PUNCTURE. 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 25094784 ↗
• MalfunctionApr 29, 2026Gas/Air Leak

  DURING A PVI PROCEDURE, AIR WAS NOTED TO BE LEAKING FROM THE VALVE DURING ASPIRATION. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037996 ↗
• MalfunctionApr 17, 2026Fluid/Blood Leak

  DURING AN ABLATION PROCEDURE, A LEAK IN THE SEAL WAS OBSERVED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915193 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A FLUID LEAK IN THE SEAL OF THE AGILIS SHEATH. THE SHEATH WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617711 ↗
• MalfunctionMar 8, 2026Gas/Air Leak

  DURING A PVI PROCEDURE, DURING ASPIRATION, AN AIR LEAK HAS BEEN DETECTED. PVI HAD BEEN PERFORMED. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542228 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS INSERTED INTO THE PATIENT, HOWEVER THE HEMOSTASIS VALVE HAD BLOOD BACKFLOW. 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 24496141 ↗
• MalfunctionFeb 17, 2026Gas/Air Leak

  DURING THE DIAGNOSTIC PROCEDURE, WHILE ASPIRATING BLOOD FROM THE SIDE PORT, 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 24368452 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, WHEN THE CATHETERS AND THE SHEATH WERE REMOVED FROM THE RIGHT VENTRICLE, THE ELECTROGRAM INDICATED THE PRESENCE OF A RIGHT BUNDLE BRANCH BLOCK. THE PATIENT ALSO UNDERWENT A CARDIAC CATHETERIZATION (CAT) AFTER THE ABLATION. THERE HAVE BEEN NO FURTHER COMPLICATIONS WITH THE PATIENT.

  Patient problems: Heart Block

  MAUDE report 23879385 ↗
• MalfunctionDec 23, 2025Fracture; Material Separation; Fracture; Material Separation

  DURING AN RF ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE SHEATH INTO THE PATIENT THE HEMOSTASIS VALVE DETACHED. UPON REMOVAL FROM THE PACKAGING, IT WAS NOTED THAT THE LUMEN HAD A CRACK. IT WAS INITIALLY THOUGHT TO BE ONLY AN AESTHETIC ISSUE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879243 ↗
• MalfunctionDec 15, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE PVI PROCEDURE, THE SHEATH WAS PLACED INTO THE PATIENT. DURING ASPIRATION, IT WAS NOTICED THAT THE HEMOSTASIS VALVE WAS DRAWING AIR. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE CONTINUED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812607 ↗
• MalfunctionDec 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS NOTED DURING AN AF PROCEDURE, AFTER PATIENT CONTACT, WHEN PURGING THE AGILIS SHEATH, BUBBLES WERE ASPIRATED BY THE SYRINGE. IT WAS NOT POSSIBLE TO STOP BUBBLE FLOW. TO RESOLVE, THE AGILIS SHEATH WAS EXCHANGED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758164 ↗
• 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 PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719817 ↗
• MalfunctionDec 4, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PVI PROCEDURE, AN AIR LEAK FROM THE VALVE WAS OBSERVED DURING ASPIRATION. THE SHEATH WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719768 ↗
• MalfunctionNov 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PFA PROCEDURE, THERE WAS A LEAK IN THE MEMBRANE OF THE SHEATH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23626097 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH LEAKED BLOOD. 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 23572834 ↗
• MalfunctionNov 13, 2025Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION CONFIRMED THAT THE LEAK OCCURRED PRIOR TO CONTACT WITH THE PATIENT, MAKING THE EVENT NOT REPORTABLE. A LEAK THAT OCCURRED OUTSIDE THE PATIENT MAY REQUIRE TROUBLESHOOTING OR REPLACEMENT OF THE DEVICE, WHICH IS LIKELY TO RESOLVE THE ISSUE AND WOULD NOT RESULT IN SERIOUS INJURY OR DEATH TO THE PATIENT. DURING DEVICE PREPARATION, PRIOR TO PATIENT CONTACT, FOR AN AF PROCEDURE USING RF ABLATION, THE VALVE WAS NOT WORKING IN THE AGILIS INTRODUCER ALLOWING AIR TO PASS THROUGH WHEN FLUSHING. TO RESOLVE, THE SHEATH WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542682 ↗
• MalfunctionNov 10, 2025Activation, Positioning or Separation Problem; Material Twisted/Bent; Activation, Positioning or Separation Problem; Material Twisted/Bent

  DURING THE SUPRAVENTRICULAR TACHYCARDIA RADIOFREQUENCY PROCEDURE, THERE WAS A DELAY. THE CATHETER COULD NOT BE INSERTED INTO THE PATIENT'S CORONARY SINUS. AFTER REMOVAL, IT WAS NOTED THAT THE TIP OF THE CATHETER WOULD NOT BEND. THE CATHETER WAS REPLACED AND THAT ISSUE WAS RESOLVED. IN ADDITION, THE SHEATH WAS BENT CLOCKWISE TO ALIGN WITH THE AXIS OF ROTATION. 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 23513579 ↗

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