LivewireRecalls & reported problems across all models

We found 5 models of Livewire by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2018 and Aug 8, 2024 — classified as 2 deaths, 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Livewire problems

Livewire models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Livewire™ 401904

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  11 reports
• Livewire™ 401908

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death6 reports
• Livewire™ 401932

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 death6 reports
• Livewire™ D402058

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• Livewire™ 401914

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report

Recent Livewire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PHYSICIAN WAS UNABLE TO PUT THE CATHETER INTO THE CORONARY SINUS BECAUSE THE CATHETER WOULD NOT DEFLECT AS EXPECTED. THE CATHETER WAS REMOVED FROM THE PATIENT AN UNKNOWN SUBSTANCE WAS NOTED TO BE ATTACHED TO THE DISTAL END DEVICE. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS NOT PROPERLY INSPECTED BY STAFF WHEN IT WAS OPENED BUT THE SALES REP SUSPECTS THAT TISSUE IN THE HEART MAY HAVE BEEN ACCIDENTALLY CAUGHT BY THE CATHETER. THE CUSTOMER SUSPECTED THAT THE SUBSTANCE SHOWN IN THE PICTURE IS THE CATHETER COATING.

  Patient problems: Foreign Body In Patient

  MAUDE report 19937659 ↗
• InjuryMar 5, 2024Entrapment of Device; Entrapment of Device

  DURING A REDO PULMONARY VEIN ISOLATION AND CTI LINE PROCEDURE, THE DIAGNOSTIC CATHETER BECAME STUCK IN THE RIGHT ATRIUM AT THE TIP AND AROUND POSITION OF ELECTRODE 19-20. IT IS UNKNOWN WHAT CAUSED THE ENTRAPMENT. DUE TO MANIPULATION THE DIAGNOSTIC CATHETER WAS BENT 1CM PROXIMAL OF ELECTRODE 19-20. THE ABLATION CATHETER WAS THEN INSERTED TO TRY TO FREE THE TIP. THIS DID NOT WORK SO THE SHEATH WAS ADVANCED OVER THE DIAGNOSTIC CATHETER FOR MORE SUPPORT. TO DO SO THE HANDLE OF THE DIAGNOSTIC CATHETER WAS CUT AND A SUTURE WAS FIXATED TO THE END. THIS WAS DONE IN ORDER TO USE THE SHEATH TO SLIDE OVER THE DIAGNOSTIC CATHETER FOR MORE SUPPORT. THE SUTURE WAS USED TO EXTEND THE GRIP OF THE DIAGNOSTIC CATHETER WHILE SLIDING THE SHEATH OVER THE DIAGNOSTIC CATHETER. THE SHEATH AND DIAGNOSTIC CATHETER WERE THEN MANIPULATED TO FREE THE CATHETER TIP. ONCE THE DIAGNOSTIC CATHETER WAS FREED, NO TISSUE WAS SEEN AT THE TIP OF THE CATHETER. THE PHYSICIAN ALLEGES THAT THE CATHETER WAS ENTANGLED IN THE CHORDAE OF THE TRICUSPID VALVE. A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED THERE WERE NO INJURIES. THE PROCEDURE WAS TERMINATED, AND PATIENT WENT BACK TO THE WARD TO BE MONITORED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18839478 ↗
• InjuryFeb 27, 2024Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, ELECTRODES 19-20 AND 3-4 BECAME PHYSICALLY STUCK TOGETHER INSIDE THE HEART AND WOULD NOT COME APART. A SNARE WAS USED TO SEPARATE THEM AND REMOVE THE CATHETER FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789083 ↗
• MalfunctionNov 8, 2023Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FLUTTER PROCEDURE, POSITIONING ISSUES WITH THE CATHETER REQUIRED TROUBLESHOOTING MEASURES AND RESULTED IN THE PROCEDURE BEING ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INTRODUCED VIA RIGHT FEMORAL ACCESS AND POSITIONED INTO THE RIGHT ATRIUM. DIFFICULTY WAS NOTED WHEN ATTEMPTING TO PLACE THE CATHETER TIP INTO THE CORONARY SINUS. ATTEMPTS TO PLACE OTHER CATHETERS INTO THE CORONARY SINUS WERE ALSO UNSUCCESSFUL. AN HOUR INTO THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS ENTANGLED IN THE RIGHT ATRIUM. DIFFERENT MANEUVERS WERE PERFORMED AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092711 ↗
• 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 ↗
• InjuryMar 15, 2023Entrapment of Device; Entrapment of Device

  DURING INSERTION OF THE CATHETER, IT BECAME STUCK IN THE ATRIUM AND THE PULL WIRES BROKE. A SNARE WAS USED TO REMOVED THE CATHETER. THE CATHETER WAS RETAINED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16550882 ↗
• 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 ↗
• InjuryFeb 2, 2022Entrapment of Device; Entrapment of Device

  DURING A PREMATURE VENTRICULAR CONTRACTIONS (PVC) ABLATION PROCEDURE, THE CATHETER WAS PLACED IN THE RIGHT ATRIUM AND WHILE ATTEMPTING TO CANNULATE THE CORONARY SINUS, THE CATHETER COULD NOT BE STRAIGHTENED COMPLETELY AND COULD NOT BE REMOVED FROM THE RIGHT ATRIUM. THE LOOP OF THE CATHETER WAS TOO LARGE TO PULL INTO THE INFERIOR VENA CAVA (IVC). AFTER APPROXIMATELY TWO HOURS, THE CATHETER WAS ABLE TO BE MANIPULATED AND THE LOOP WAS STRAIGHTENED WITH THE USE OF AN ABLATION CATHETER AND STEERABLE SHEATH. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER FROM THE SAME MODEL AND LOT TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423881 ↗
• InjuryDec 15, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CATHETER BECAME BENT AND A SNARE WAS NEEDED TO REMOVE THE DEVICE. THE CATHETER WAS PLACED INTO THE RIGHT ATRIUM, THE ACTUATOR HANDLE WAS TURNED TO PLACE INTO THE DEVICE INTO THE CORONARY SINUS (CS). THE PHYSICIAN STATED THE PATIENTS ATRIUM WAS NORMAL SIZE AND HE WAS HAVING DIFFICULTIES CANNULATING THE CS. AN ATTEMPT TO STRAIGHTEN THE CURVE OF THE CATHETER WAS UNSUCCESSFUL. THE DEVICE WAS ABLE TO BE ROTATED 360 DEGREES WITHOUT RESISTANCE. THE CATHETER COULD NOT BE ADVANCED INTO THE SVC, IVC, OR RV, WHEN ATTEMPTING TO STRAIGHTEN AND REMOVE THE CATHETER. AFTER ATTEMPTING TO REMOVE THE CATHETER FOR APPROXIMATELY 30 MINUTES, A SNARE WAS PLACED INTO THE RIGHT ATRIUM AND ATTACHED TO THE DISTAL PORTION OF THE CATHETER. WHILE HOLDING THE DISTAL PORTION STABLE, THE CATHETER WAS ABLE TO BE REMOVED. THE CATHETER WAS REPLACED WITH A DEVICE FROM THE SAME MODEL WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011834 ↗
• 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 ↗
• InjuryMar 8, 2021Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, WHEN ATTEMPTING TO POSITION THE CATHETER INTO THE CORONARY SINUS IT BECAME ENTANGLED ON ITSELF AND A SNARE WAS USED FOR REMOVAL. ELECTRODES 5-6 APPEARED TO BE CAUGHT ON ELECTRODES 19-20. SEVERAL DIFFERENT WAYS TO WERE TRIED TO RELEASE THE DEVICE WITH NO SUCCESS. SEVERAL CATHETERS WERE ATTEMPTED TO PASS THROUGH THE CENTER OF THE LOOP ON THE LIVEWIRE UNSUCCESSFULLY. AFTER APPROXIMATELY AN HOUR, A SNARE CATHETER WAS USED WITH FORCE AND THE CATHETER WAS UNTANGLED AND REMOVED FROM THE PATIENT. THE PATIENT HAD TOO MUCH X-RAY AND HAD BEEN UNDER ANESTHESIA FOR TOO LONG AND THE CASE WAS CANCELLED. VISIBLE KINKS WERE NOTED WHERE THE CATHETER WAS CAUGHT ON ITSELF. THE PATIENT WAS NOT HARMED BUT DID RECEIVE SEVERAL X-RAYS AND WAS UNDER GENERAL ANESTHESIA FOR A FEW HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440358 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 3008452825-2020-00567; 2182269-2020-00093. DURING A RIGHT VENTRICULAR OUTFLOW TRACT PREMATURE VENTRICULAR CONTRACTION ABLATION, A PERICARDIAL EFFUSION WAS OBSERVED AND THE PROCEDURE WAS CANCELLED. WHILE ABLATING THE ANTERIOR ASPECT, HYPOTENSION WAS NOTED, AND A PERICARDIAL EFFUSION WAS FOUND VIA ULTRASOUND. THE CASE WAS ABANDONED, AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 10800567 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2020-00465, 3005334138-2020-00466, 3008452825-2020-00521, 2030404-2020-00083. AT THE END OF A PVC ABLATION PROCEDURE, DURING RF OF THE LAST LESION, A PERICARDIAL EFFUSION OCCURRED. THE DUO CATHETER WAS PLACED IN THE CORONARY SINUS AND THE FLEXIBILITY WAS USED FOR ABLATION OF THE PVC'S IN THE RIGHT VENTRICLE. REINFORCEMENT OF THE LESIONS IN THE RIGHT VENTRICLE WERE VERIFIED TO CONFIRM ELIMINATION OF THE ARRHYTHMIA. HOWEVER, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10669300 ↗

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