SJM™ G402047Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734216418), received between Aug 1, 2019 and Jun 26, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Gas/Air Leak; Gas/Air Leak

  DURING A VEIN OF MARSHALL ALCOHOL ABLATION PROCEDURE, AN AIR LEAK OCCURRED. THE INTRODUCER WAS IN THE ENDOCARDIAL SPACE. ACCESS WAS OBTAINED THROUGH THE INTERNAL JUGULAR (IJ) AND THE INTRODUCER WAS BEING USED TO GAIN ACCESS TO THE CORONARY SINUS (CS) OSTIUM FROM ABOVE. WHILE IN THE HEART, THE PHYSICIAN WAS "PULLING BACK" AIR ONLY (NOT BLOOD) THROUGH THE SHEATH. IT WAS CONFIRMED THAT THE DEVICE WAS IN THE HEART, NOT THE LUNGS. THE PHYSICIAN FELT THAT THE HEMOSTASIS VALVE WAS COMPROMISED, AND THE AIR WAS BEING PULLED THROUGH THE VALVE. UPON REMOVING THE INTRODUCER FROM THE PATIENT, THE PHYSICIAN HAD TROUBLE RE-INSERTING THE DILATOR INTO 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 19616314 ↗
• MalfunctionFeb 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS EVENT IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706544 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE 3005334138-2019-00420 DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. DURING EPICARDIAL ACCESS WITH THE AGILIS INTRODUCER AND ADVISOR HD GRID CATHETER, THE HEART WAS PERFORATED. TO STABILIZE THE PATIENT AND REPAIR THE PERFORATION, STERNOTOMY WAS PERFORMED AND THE PATIENT WAS PUT ON CARDIOPULMONARY BYPASS FOR OPEN HEART SURGERY. THE USER ELECTED NOT TO PERFORM THE SCHEDULED ABLATION PROCEDURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8850742 ↗