Livewire™ 401908Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734202558), received between Oct 3, 2018 and Sep 27, 2021 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathSep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE, A PERICARDIAL EFFUSION AND SUBSEQUENT PERICARDIAL TAMPONADE OCCURRED AND THE PATIENT PASSED AWAY. WHILE MAPPING WITH THE ADVISOR HD GRID AND THE LIVEWIRE CATHETERS, THE PATIENT EXPERIENCED A LARGE EFFUSION AROUND THE RIGHT VENTRICLE WHICH TURNED INTO A CARDIAC TAMPONADE. A PERICARDIAL WINDOW WAS PERFORMED, BUT THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY. CHEST COMPRESSIONS WERE PERFORMED BUT THE PATIENT WAS UNABLE TO BE REVIVED AND THE PATIENT PASSED AWAY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN ALLEGED THE PERFORATION WAS CAUSED BY THE LIVEWIRE CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 12533258 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  DURING A VENTRICULAR TACHYCARDIA (VT) PROCEDURE, IT WAS NOTED AN ELECTRODE WAS DISPLACED ON THE CATHETER. THE CABLE WAS EXCHANGED AND THE PIN LOCATION WAS CHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AND THE PROCEDURE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11677684 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2020-00255, 3008452825-2020-00256, 3008452825-2020-00257, 2182269-2020-00051. DURING VENTRICULAR TACHYCARDIA MAPPING IN THE LEFT VENTRICLE, A PERICARDIAL EFFUSION OCCURRED. AFTER APPROXIMATELY AN HOUR OF MAPPING, USING TRANSSEPTAL APPROACH, THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS ADMINISTERED. AN ADDITIONAL ULTRASOUND CONFIRMED A LEFT HEMOTHORAX, WHICH REQUIRED A DRAIN. THE CAUSE AND LOCATION OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN, HOWEVER IT WAS NOTED THE TRANSSEPTAL PUNCTURE WAS DIFFICULT. THE PATIENT WAS STABLE WITH MINIMAL USE OF CATECHOLAMINES AND TRANSFERRED TO THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Hemothorax

  MAUDE report 10098867 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00176, 3008452825-2019-00177, 3005334138-2019-00204.

  Patient problems: Cardiac Perforation

  MAUDE report 8498164 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. AFTER MAPPING FOR APPROXIMATELY 1 HOUR IN THE LEFT VENTRICLE, THE CATHETER WAS NOTED TO MOVE OUTSIDE THE GEOMETRY. THE PATIENT BECAME AGITATED AND AN ECHOCARDIOGRAM REVEALED A SMALL PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT ULTIMATELY THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE PERFORATION WITHIN THE LATERAL LEFT VENTRICLE. THE PATIENT REMAINED IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8266400 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 9680001-2018-00149, 3008452825-2018-00341, 2182269-2018-00127 . FOLLOWING A VT ABLATION PROCEDURE, A TAMPONADE OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO PERFORMANCE ISSUES NOTED AND AN ECHOCARDIOGRAM IMMEDIATELY FOLLOWING THE PROCEDURE WAS NORMAL. THE DAY FOLLOWING, THE PATIENT DIDN¿T FEEL WELL. AN ECHOCARDIOGRAM REVEALED A TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 7931535 ↗