Livewire™ D402058Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734216890), received between Aug 8, 2018 and Nov 19, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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.

• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY SINUS CANNULATION, A DISSECTION OCCURRED. NO INTERVENTION WAS REQUIRED TO TREAT THE DISSECTION AND THE PATIENT REMAINED STABLE. ANOTHER PROCEDURE WILL BE SCHEDULED ONCE THE DISSECTION HEALS.

  Patient problems: Vascular Dissection

  MAUDE report 9340332 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00195, 3008452825-2019-00160. DURING A REDO PULMONARY VEIN ISOLATION PROCEDURE, THE LEFT ATRIUM WAS SUCCESSFULLY ABLATED NEAR THE PULMONARY VEINS AND THE CATHETERS WERE WITHDRAWN TOWARD THE RIGHT ATRIUM. AFTER WITHDRAWING THE CATHETERS TO THE RIGHT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. AN INTRACARDIAC ECHOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND A DRAIN WAS INSERTED UNTIL THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8499205 ↗
• InjuryAug 8, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ENDOCARDIAL VENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHILE MAPPING IN THE LEFT VENTRICLE THE CATHETER WAS UNABLE TO BE VISUALIZED AND THE SIGNAL OF ELECTRODE 3 WAS LOST. ELECTRODE 3 WAS HIDDEN FROM THE MAPPING SCREEN IN ORDER TO CONTINUE THE CASE. WHILE MAPPING, THE CATHETER WAS OBSERVED OUTSIDE OF THE LEFT VENTRICLE AND INTO THE PERICARDIUM ON THE LATERAL WALL. THE PROCEDURE WAS STOPPED AND AN ULTRASOUND REVEALED A PERICARDIAL EFFUSION. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 7761384 ↗