Livewire™ 401940Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734202688), received between May 23, 2019 and Oct 27, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REF: (B)(4). DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, THE ENSITE DWS COULD NOT DISPLAY THE ELECTRODE IMAGE WHICH CAUSED A DELAY. THE DWS AND AMPLIFIER WERE RESTARTED AND RECONNECTED WITH NO RESOLUTION. THE PATCHES WERE THEN REPLACED WHICH RESOLVED THE ISSUE. ADDITIONALLY, ELECTRODES 7-8 OF THE CATHETER DID NOT DISPLAY AS EXPECTED IN THE RIGHT ATRIUM. THE CABLE AND THE POLE IN THE JUNCTION BOX WERE CHANGED WITH NO RESOLUTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022628 ↗
• MalfunctionJun 21, 2023Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURE REF: 2182269-2023-00028. DURING WOLFE PARKINSON WHITE (WPW) PROCEDURE, DISTORTION WAS NOTED ON ELECTRODE 2 OF THE CATHETER. A SECOND CATHETER FROM THE SAME LOT WAS USED AND THE SAME ISSUE WAS NOTED ON ELECTRODE 9. THE CABLES WERE REPLACED AND AMPERE INPUTS WERE CHANGED WITH NO RESOLUTION. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171884 ↗
• MalfunctionJun 21, 2023Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURE REF: (B)(4). DURING WOLFE PARKINSON WHITE (WPW) PROCEDURE, DISTORTION WAS NOTED ON ELECTRODE 2 OF THE CATHETER. A SECOND CATHETER FROM THE SAME LOT WAS USED AND THE SAME ISSUE WAS NOTED ON ELECTRODE 9. THE CABLES WERE REPLACED AND AMPERE INPUTS WERE CHANGED WITH NO RESOLUTION. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171866 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00200, 3008452825-2020-00251, 3005334138-2020-00201, 3008452825-2020-00252. TWO DAYS FOLLOWING AN ABLATION PROCEDURE, THE PATIENT DEVELOPED A CEREBROVASCULAR ACCIDENT. THE CIRCUMFERENTIAL FOUR PULMONARY VEIN ISOLATION AND CAVOTRICUSPID ISTHMUS ABLATION PROCEDURE WAS PERFORMED ON (B)(6) 2020 WITH NO REPORTED ISSUES. THE PATIENT WAS ANTICOAGULATED DURING THE PROCEDURE WITH AN ACTIVE CLOTTING TIME VALUE OF GREATER THAN 300, AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. ON (B)(6) 2020 A HEAD CT AND MRI WERE PERFORMED, REVEALING AN ACUTE-TO-SUBACUTE CEREBRAL INFARCTION OVER THE RIGHT FRONTAL AND TEMPORAL OPERCULA REGION. IT WAS SUSPECTED THAT THERE WAS A THROMBUS IN THE CORTICAL BIFURCATION OF THE INFERIOR SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT WAS HOSPITALIZED FOR IV FLUIDS AND ANTICOAGULANTS, REMAINING IN STABLE CONDITION. A REPEAT HEAD CT REVEALED NO INTRACRANIAL HEMORRHAGE AND THE PATIENT WAS DISCHARGED ON (B)(6) 2020 WITH NO RESIDUAL NEUROLOGICAL DEFICITS.

  Patient problems: Stroke/CVA

  MAUDE report 10088465 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3005334138-2019-00256. DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE A CARDIAC TAMPONADE OCCURRED. DURING THE PROCEDURE, FOLLOWING ABLATION OF THE POSTEROLATERAL LA, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIOCENTESIS WAS PERFORMED. TRANSOESOPHAGEAL ECHO CONFIRMED THE EFFUSION AND SURGICAL INTERVENTION WAS PERFORMED AND INCLUDED PLACING PATCHES AROUND THE PROXIMAL CORONARY SINUS OS TO STABILIZE THE PATIENT. THE PATIENT WAS STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8635811 ↗