Agilis™ G408321Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734206143), received between Feb 7, 2019 and Jan 7, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Fluid/Blood Leak; Difficult to Insert

  IT WAS ORIGINALLY REPORTED THAT THE INTRODUCER LEAKED. FURTHER INFORMATION CONFIRMED THAT DURING THE PROCEDURE, IT WAS ALLEGED THAT THE INTRODUCER "LUMEN WAS UNCOMMONLY TIGHT" FOR THE INTRODUCER. THERE WAS NO AIR OR FLUID LEAK. 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 23996046 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak; Difficult to Insert

  IT WAS ORIGINALLY REPORTED THAT THE INTRODUCER LEAKED. FURTHER INFORMATION CONFIRMED THAT DURING THE PROCEDURE, IT WAS ALLEGED THAT THE INTRODUCER "LUMEN WAS UNCOMMONLY TIGHT" FOR THE INTRODUCER. THERE WAS NO AIR OR FLUID LEAK. 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 23996045 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak; Difficult to Insert

  IT WAS REPORTED THAT THE INTRODUCER LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995909 ↗
• InjurySep 10, 2025Difficult to Insert; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  DURING ABLATION PROCEDURE, THE AGILIS PERFORATED THE ILIAC VEIN. THERE WAS DIFFICULTY INSERTING THE AGILIS, THE SHEATH HAD KINKED AT THE ILIAC VEIN ABOVE THE PELVIC RIM. THE SHEATH WAS REMOVED AND THE GUIDEWIRE WAS LEFT IN. SHORTLY AFTER, THE BLOOD PRESSURE DROPPED AND A VENOGRAM CONFIRMED EXTRAVASATION AT THE ILIAC VEIN. THE PATIENT REQUIRED STENTING TO RESOLVE THE ISSUE.

  Patient problems: Perforation

  MAUDE report 23020148 ↗
• MalfunctionOct 19, 2023Gas/Air Leak; Gas/Air Leak

  DURING ASPIRATION OF THE SHEATH, A CONTINUOUS STREAM OF BUBBLES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966670 ↗
• MalfunctionMay 25, 2023Material Separation; Material Separation

  DURING DEVICE PREPARATION FOR THE RIGHT ATRIAL TYPICAL ATRIAL FLUTTER PROCEDURE, WHILE FLUSHING THE SHEATH, IT WAS NOTED THAT THE END OF THE SHEATH WITH THE SIDE FLUSH PORT BECAME SEPARATED FROM THE HANDLE. 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 17001884 ↗
• MalfunctionJan 21, 2022Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURER REF: 3008452825-2022-00023. DURING THE PROCEDURE, AFTER INSERTING THE INTRODUCER INTO THE PATIENT, AIR WAS ASPIRATED. THE INTRODUCER WAS EXCHANGED AND ANOTHER INTRODUCER WAS INSERTED INTO THE PATIENT, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE SECOND INTRODUCER DESPITE THE ISSUE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314507 ↗
• MalfunctionJan 21, 2022Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURER REF: 3008452825-2022-00024. DURING THE PROCEDURE, AFTER INSERTING THE INTRODUCER INTO THE PATIENT, AIR WAS ASPIRATED. THE INTRODUCER WAS EXCHANGED AND ANOTHER INTRODUCER WAS INSERTED INTO THE PATIENT, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE SECOND INTRODUCER DESPITE THE ISSUE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314503 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE ABLATION CATHETER ENTERED THE PERICARDIAL SPACE. INITIALLY FOLLOWING THE COLLECTING OF GEOMETRY IN THE LEFT ATRIUM, THE PHYSICIAN WANTED TO CONDUCT SOME FALLING POINTS WITH THE ABLATION CATHETER IN THE LEFT SUPERIOR PULMONARY VEIN, HOWEVER THE CATHETER WAS NOT ABLE TO MOVE FREELY IN THE LEFT ATRIUM. THE PHYSICIAN THEN NOTED THE ABLATION CATHETER WAS IN THE PERICARDIAL SPACE. AN ECHOCARDIOGRAM WAS CONDUCTED, BUT NO BLEEDING OR PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT'S BLOOD PRESSURE REMAINED STABLE. NO INTERVENTION WAS ADMINISTERED AND THE PROCEDURE WAS CANCELLED. THE PHYSICIAN BELIEVED THE PERFORATION OCCURRED DURING THE TRANSSEPTAL PUNCTURE WITH THE INTRODUCER, WHICH IS HOW THE ABLATION CATHETER ENTERED THE PERICARDIAL SPACE IN THE SEPTAL WALL. THE PHYSICIAN DID NOT ALLEGE THE ABLATION CATHETER CAUSED THE PERFORATION. THERE WERE NO PERFORMANCE ISSUES WITH THE INTRODUCER.

  Patient problems: Cardiac Perforation

  MAUDE report 12916134 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE, THE HEMOSTATIC PORTION OF THE SHEATH CAME APART. THE INTRODUCER WAS REMOVED NORMALLY AND ANOTHER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8315242 ↗

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