Livewire™ 401575Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734202183), received between Dec 1, 2018 and May 6, 2022 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2022Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  RELATED MANUFACTURING REF: 3008452825-2022-00407, 3008452825-2022-00408. DURING A SUPRAVENTRICULAR ABLATION PROCEDURE WITH WOLFE PARKINSON WHITE SYNDROME, A PERICARDIAL EFFUSION WAS NOTED IN THE CORONARY SINUS. DURING THE PROCEDURE, ELECTRODE 7-8 OF THE STEERABLE CATHETER SHOWED NOISE AND STRETCHING ON THE SYSTEM SCREEN AND THE PHYSICIANS INVOLVED STATED HIGH IMPEDANCE WAS NOTED. THE SIGNALS OF CS 7-8 WERE HIDDEN FROM BOTH THE ENSITE PRECISION AND THE EP RECORDING SYSTEM TO CONTINUE THE PROCEDURE. ACCESS THE CORONARY SINUS (CS) WAS ATTEMPTED WITH THE STEERABLE CATHETER, AND SUBSEQUENTLY WITH THE HELP OF THE SL3 SHEATH. A NON ABBOTT GUIDEWIRE WAS THEN USED TO GUIDE THE CS CATHETER. AFTER THE CATHETERS WERE IN PLACE, THE STUDY WAS PERFORMED. THE PATIENT THEN BECAME RESTLESS AND STATS DROPPED TO APPROXIMATELY 70+. AN ECHO WAS THEN PERFORMED WHICH REVEALED AN EFFUSION. HOWEVER, THE PROCEDURE WAS ABANDONED MIDWAY THROUGH THE STUDY AS THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 14306228 ↗
• MalfunctionJan 28, 2021Signal Artifact/Noise; Signal Artifact/Noise

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A SHORT CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248721 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: (B)(4). DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, AN EFFUSION OCCURRED. A CORONARY SINUS CATHETER WAS PLACED AND THEN AN ABLATION CATHETER WAS USED TO MAP THE RIGHT VENTRICULAR OUTFLOW TRACT (RV/RVOT). A MAP OF THE CHAMBER WAS DONE UP AND PAST THE PULMONARY VALVE/PULMONARY ARTERY. THE ABLATION CATHETER WAS DIFFICULT TO KEEP STABLE, SO A SHEATH WAS PLACED TO FURTHER MAP THE RIGHT OUTFLOW TRACT CHAMBER AND AN AREA WAS FOUND IN LOWER OUTFLOW TRACT TRICUSPID VALVE. FOUR LESIONS WERE MADE IN THAT AREA AND WAS STILL INDUCIBLE AND THE PATIENT BECAME HYPOTENSIVE. A SECOND ATTEMPT TO PLACE AN ICE CATHETER WAS DONE TO ASSIST WITH NAVIGATION OF THE CATHETERS. THE FIRST ATTEMPT WAS ABANDONED AS THERE WAS TORTUOSITY OF THE VEIN, HOWEVER THIS TIME A LONGER VASCULAR SHEATH WAS USER AND THE ICE CATHETER WAS SUCCESSFULLY PLACED IN RIGHT ATRIUM WHERE AN EFFUSION WAS NOTED. A PERICARDIOCENTESIS AND TRANSFUSION WERE PERFORMED. A CODE WAS CALLED TO RESUSCITATE THE PATIENT AS THERE WERE SEVERAL EPISODES OF VENTRICULAR FIBRILLATION REQUIRING DEFIBRILLATION AND THE PATIENT WAS TRANSFERRED TO SURGERY FOR AN OPEN-HEART PERICARDIAL WINDOW. THE PATIENT WAS EXTUB

  Patient problems: Cardiac Perforation

  MAUDE report 10667553 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2020-00305, 3005334138-2020-00306, 3008452825-2020-00354, 3008452825-2020-00355, 3005334138-2020-00307. FOLLOWING AN ABLATION PROCEDURE, A POSSIBLE STROKE AND CEREBRAL EDEMA OCCURRED. THE ABLATION WAS COMPLETED SUCCESSFULLY WITH NO ABNORMALITIES. THE PATIENT WAS TRANSFERRED TO CORONARY CARE UNIT TO BE FOLLOWED. THE EVENING OF THE ABLATION PROCEDURE, ASSESSMENT AND INVESTIGATION OF ACUTE ISCHEMIC STROKE WAS ADMINISTERED. THE FOLLOWING DAY, THE PATIENT WITHDREW FROM THE CLINICAL STUDY. A CT ON (B)(6) 2020 REVEALED A SMALL CALIBER OF DISTAL M1 AND DECREASED VASCULARITIES OF THE LEFT SIDE MIDDLE CEREBRAL ARTERY, COMPATIBLE WITH ACUTE OCCLUSION OF THE M1 MIDDLE CER. THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY AND WAS STABILIZED. A DYNA-CT SHOWED NO OBVIOUS INTRACEREBRAL HEMORRHAGE (ICH). THE PATIENT WAS FOLLOWED IN NCUA. ALTERED MENTAL STATUS WAS NOTED AND A BRAIN CT SHOWED BRAIN EDEMA WITHOUT ICH. EMERGENCY DECOMPRESSIVE CRANIECTOMY AND ICP INSERTION WAS ADMINISTERED. PRIOR TO PROCEDURE, IT WAS CONFIRMED THERE WAS NO THROMBUS AND THE ACTIVE CLOTTING TIME DURING THE PROCEDURE WAS BETWEEN 200 AND 270. THOUGH THERE IS NO INDICATION A DEVICE

  Patient problems: Edema; Stroke/CVA

  MAUDE report 10307211 ↗
• InjuryMar 10, 2020Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, THE CATHETER BECAME ENTRAPPED IN A POSTERIOR BRANCH OF THE EYELET VEIN. DUE TO DIFFICULT DEVICE REMOVAL, THE CATHETER WAS LEFT IN THE PATIENT FOR THE REMAINDER OF THE PROCEDURE. AT THE END OF THE CASE, THE DEVICE WAS STILL STUCK SO THE DEFLECTION MECHANISM WAS CUT OFF TO ALLOW A SHEATH TO ADVANCE OVER THE CATHETER SHAFT. A DOSE OF VERAPAMIL WAS ADMINISTERED AND THE CATHETER WAS REMOVED SUCCESSFULLY. FLUOROSCOPY WAS USED WITH CONTRAST TO OBSERVE THE VEIN BUT THE VEIN WAS FUNCTIONING PROPERLY AND NO DAMAGE WAS NOTED. THE PHYSICIAN DID NOT BELIEVE THE EVENT WAS DUE TO A PERFORMANCE ISSUE WITH THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9810638 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 3008452825-2020-00113, 2030404-2020-00013, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9744997 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3008452825-2019-00630, 3005334138-2019-00807, 3005334138-2019-00808. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER A DIFFICULT TRANSSEPTAL ACCESS WAS OBTAINED AND MULTIPLE RE-CROSSINGS OF THE SEPTUM OCCURRED, MAPPING AND ABLATION OF THE RIGHT LOWER PULMONARY VEIN WAS STARTED. AS THE MAPPING CATHETER WAS BEING MANIPULATED, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9509847 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A 3D MAPPING PROCEDURE, THE CATHETER BECAME LODGED IN A SMALL BRANCH OFF THE RIGHT FEMORAL VEIN AND COULD NOT BE REMOVED. OTHER CATHETERS WERE SUCCESSFULLY INTRODUCED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT END OF CASE, THE CATHETER WAS STILL LODGED IN THE VEIN. GLYCERYL TRINITRATE WAS GIVEN TO RELAX THE VEINS AND WITH SOME FORCE, THE CATHETER WAS REMOVED. INSPECTION OF THE DEVICE REVEALED TISSUE ON THE CATHETER TIP.

  Patient problems: Tissue Damage

  MAUDE report 8951034 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00239, 2182269-2019-00064, 3008452825-2019-00243, 2182269-2019-00066. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC EFFUSION OCCURRED. DURING ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI), A POTENTIAL STEAM POP OCCURRED, HOWEVER IT COULD NOT BE CONFIRMED. THE PROCEDURE WAS ABLE TO BE COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. INTRA-CARDIAC ECHOCARDIOGRAPHY(ICE) CONFIRMED AN EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8631890 ↗
• InjuryDec 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CARDIAC RESYNCHRONIZATION THERAPY IMPLANT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE CPS DIRECT UNIVERSAL SLIT TABLE OUTER CATHETER WAS PLACED INTO THE CORONARY SINUS WITH GUIDANCE OF THE LIVEWIRE CATHETER. THEN A BALLOON CATHETER WAS INSERTED AND INFLATED BUT THE VENOGRAM WASN'T CLEAR SO THE BALLOON WAS DEFLATED AND REMOVED. THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND ADRENALINE WAS ADMINISTERED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 8122944 ↗