Livewire™ 401932Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734202626), received between Jan 10, 2019 and Sep 27, 2023 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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. 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.

• MalfunctionSep 27, 2023Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER BECAME ENTANGLED REQUIRING THE USE OF A SNARE TO SUCCESSFULLY REMOVE THE CATHETER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AT THE BEGINNING OF THE PROCEDURE IN VOXEL MODE, WHILE PLACING THE CATHETER, IT BECAME LOOPED AND CAUGHT AND WAS DIFFICULT TO UNLOOP TO REMOVE. A SNARE WAS USED TO REMOVE FROM THE HEART AND THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PHYSICIAN DOES NOT ALLEGE ANY PERFORMANCE ISSUES OR DEVICE MALFUNCTION WITH THE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17825851 ↗
• MalfunctionSep 19, 2023Entrapment of Device; Activation, Positioning or Separation Problem; Entrapment of Device; Activation, Positioning or Separation Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, WHILE ATTEMPTING TO POSITION THE CATHETER WITHIN THE HEART, THE CATHETER BECAME LODGED INSIDE THE EUSTACHIAN RIDGE. RIGHT INTERNAL JUGULAR VEIN ACCESS WAS OBTAINED AND A NON-ABBOTT CATHETER (DEFLECTABLE ST-SF F-CURVE BIOSENSE WEBSTER) WAS USED TO SNARE THE LOOP OF THE CATHETER FROM ABOVE. THE CATHETER WAS REMOVED SUCCESSFULLY VIA THE FEMORAL VEIN AND A NON-ABBOTT CATHETER (BIOSENSE WEBSTER CS EZ STEER) TO COMPLETE THE PROCEDURE WITH NO FURTHER ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17778365 ↗
• InjuryNov 10, 2022Entrapment of Device; Entrapment of Device

  VOLUNTARY MEDWATCH # MW5112872 DURING THE DIAGNOSTIC PORTION OF AN ATRIAL FLUTTER PROCEDURE, A DUO-DECA DIAGNOSTIC CATHETER GOT STUCK WITHIN THE CHIARA NETWORK OF THE HEART AND REQUIRED A SNARE TO BE REMOVED. CARDIOLOGY CONTACTED INTERVENTIONAL CARDIOLOGY AND VASCULAR SURGERY FOR ASSISTANCE IN SAFELY REMOVING THE DEVICE. ADDITIONAL ACCESS WAS GAINED VIA THE IJ VEIN AND THE DEVICE WAS SNARED AND FREED FROM THE HEART WALL AND THEN SUCCESSFULLY REMOVED WHILE USING ECHO. AN INTRACARDIAC ECHO WAS PERFORMED BEFORE, DURING, AND AFTER TO ENSURE NO DAMAGE WAS DONE TO THE PATIENT. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776457 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2020-00194, 3005334138-2020-00195, 2182269-2020-00045. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. ISOLATION OF THE LEFT PULMONARY VEINS WAS ACHIEVED. AFTER ISOLATING THE RIGHT VEINS, THE PATIENT BECAME HYPOTENSIVE AND ICE WAS USED TO IDENTIFY A PERICARDIAL EFFUSION. A PERICARDIALCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10089523 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00404, 3008452825-2019-00405, 3008452825-2019-00407. DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE A DISSECTION OCCURRED. DURING THE PROCEDURE, AS THE PHYSICIAN WAS GUIDING THE DEVICES THROUGH A NARROW LEFT ILIAC VEIN, THE PATIENT BECAME HYPOTENSIVE. A HEMOGLOBIN TEST WAS RUN AND IT WAS DETERMINED THE PATIENT NEEDED A BLOOD TRANSFUSION. CONTRAST WAS INJECTED TO DETERMINE THE LOCATION OF THE BLEEDING AND A DISSECTION WAS FOUND. VASCULAR INTERVENTION WAS NOT REQUIRED AS THE DISSECTION CLOSED ON ITS OWN. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 8883686 ↗
• DeathJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00129, 9680001-2019-00004, 3005334138-2019-00020, 3005334138-2019-00021, 3005334138-2019-00022, 3005334138-2019-00023. FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION AND EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ANTICOAGULATED WITH HEPARIN AND THE ACT MONITORING WAS MADE IN 30-MINUTE INTERVALS. AFTER THE PROCEDURE THE PATIENT DID NOT WAKE UP FROM ANESTHESIA AND SUBSEQUENTLY EXPIRED. THERE WERE NO PERFORMANCE ISSUE WITH THE DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE CVA.

  Patient problems: Death; Myocardial Infarction; Stroke/CVA

  MAUDE report 8237206 ↗