Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067051844), received between Jun 10, 2025 and Feb 20, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Gas/Air Leak

  DURING THE PULSED FIELD ABLATION PROCEDURE, AIR ASPIRATED FROM THE VALVE WHEN THE VOLT CATHETER WAS INSERTED. THE SHEATH WAS REPLACED BUT THE SAME ISSUE OCCURRED. THE SHEATH WAS REPLACED AGAIN AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATHS WERE FLUSHED PROPERLY WITH EACH FLUSH PERFORMED BEFORE INTRODUCING THE VOLT CATHETER AND ONLY BLOOD WAS ASPIRATED, WITH NO BUBBLES. AIR WAS NOTED AFTER THE VOLT CATHETER WAS INSERTED. AS SOON AS THE VOLT WAS INSERTED, LARGE AIR BUBBLES WERE ASPIRATED. THE ISSUE DISAPPEARED WHEN THE VOLT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402698 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Gas/Air Leak; Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE USING PULSED FIELD ABLATION, THERE WAS A BLOOD AND AIR LEAK FROM THE SHEATH. THE SHEATH WAS PREPARED AND INSERTED INTO THE PATIENT. AFTER A SUCCESSFUL TRANSSEPTAL, THERE WAS NO AIR IN THE INITIAL ASPIRATION. WHILE MAPPING WITH THE DIAGNOSTIC CATHETER, BLEED BACK AND AIR WERE NOTED DURING ASPIRATION. 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 23594014 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PVI PROCEDURE WITH NON-ABBOTT (NON-ESI FARAPULSE BY BOSTON SCIENTIFIC), BLEED BACK FROM THE VALVE OF THE SHEATH WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424414 ↗
• InjuryAug 21, 2025Gas/Air Leak; Gas/Air Leak

  DURING AF ABLATION PROCEDURE, AN AIR LEAK OCCURRED WHICH LED TO AN AIR EMBOLISM AND TRANSIENT ST ELEVATION. THERE WERE NO ISSUES WITH THE DEVICE DURING PREP; HOWEVER, AIR WAS NOTED TO BE LEAKING FROM THE HEMOSTATIC VALVE WHEN PULLING BACK AFTER TRANSSEPTAL. THE PHYSICIAN CONTINUED TO USE THE DEVICE. LATER IN THE PROCEDURE WHILE EXCHANGING THE PFA CATHETER TO THE MAPPING CATHETER, THE PATIENT EXPERIENCED TRANSIENT ST ELEVATION WHICH THE PHYSICIAN BELIEVED TO BE LINKED TO THE DEFECTIVE SHEATH. THE SHEATH WAS ASPIRATED TWICE WITH A 20CC SYRINGE. PATIENT WAS DISCHARGED.

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 22860634 ↗
• MalfunctionJun 10, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE VALVE FROM THE 13F AGILIS WAS LEAKING FOLLOWING TRANSEPTAL. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175842 ↗