LivewireRecalls & reported problems across all models
St. Jude Medical Cardiovascular Division · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 10 models of Livewire by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2018 and May 6, 2024 — classified as 17 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Signal Artifact/Noise” (8 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
Reports received per month, all models
Most reported Livewire problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Signal Artifact/Noise8
- Electrical Shorting5
- Contamination /Decontamination Problem1
- Display or Visual Feedback Problem1
- Entrapment of Device1
- Patient Device Interaction Problem1
Patient problems
- Cardiac Perforation11
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient3
- Stroke/CVA2
- Complete Heart Block1
- Edema1
- Tissue Damage1
- Vascular Dissection1
Livewire models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Livewire™ 401575CATHETER, STEERABLE10 reports
- Livewire™ 401940CATHETER, STEERABLE5 reports
- Livewire™ 402151Cardiac ablation percutaneous catheter4 reports
- Livewire™ 402152Cardiac ablation percutaneous catheter2 reports
- Livewire™ 401582CATHETER, STEERABLE2 reports
- Livewire™ 401915CATHETER, STEERABLE2 reports
- Livewire™ 402022CATHETER, STEERABLE2 reports
- Livewire™ 401786CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Livewire™ 401923CATHETER, STEERABLE1 report
- Livewire™ 402032CATHETER, STEERABLE1 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.
MalfunctionMay 6, 2024Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT FOUND IN THE CATHETER DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249484 ↗MalfunctionMay 3, 2024Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19242896 ↗MalfunctionNov 10, 2023Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT THAT WAS NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18115040 ↗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 ↗MalfunctionJul 28, 2023Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF A SHORT CIRCUIT THAT WAS NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17419824 ↗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 ↗MalfunctionJun 7, 2023Signal Artifact/Noise; Signal Artifact/Noise
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, NOISE ISSUES RESULTING IN MULTIPLE EXCHANGES WHICH CAUSED PROCEDURAL DELAYS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE CONNECTING CABLE BUT NOISE WAS NOTED ON THE ELECTRIC POTENTIALS 1-2 AND ELECTRIC POTENTIAL COULD NOT READ. THE CONNECTING CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED TO A SECOND ONE OF SAME LOT NUMBER WITH NO RESOLUTION. THE CATHETER WAS REPLACED TO A THIRD ONE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17077734 ↗MalfunctionJun 6, 2023Signal Artifact/Noise; Signal Artifact/Noise
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, NOISE ISSUES RESULTING IN MULTIPLE EXCHANGES WHICH CAUSED PROCEDURAL DELAYS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INSERTED INTO THE HEART AND CONNECTED TO THE CONNECTING CABLE BUT NOISE WAS NOTED ON THE ELECTRIC POTENTIALS 1-2 AND ELECTRIC POTENTIAL COULD NOT READ. THE CONNECTING CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED TO A SECOND ONE OF SAME LOT NUMBER WITH NO RESOLUTION. THE CATHETER WAS REPLACED TO A THIRD ONE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17075666 ↗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 ↗MalfunctionFeb 10, 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 11311250 ↗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 ↗MalfunctionNov 26, 2020Electrical Shorting; Electrical Shorting
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, CONFIRMING A SHORT CIRCUIT IDENTIFIED WITHIN THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10908821 ↗MalfunctionNov 3, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
DURING THE PROCEDURE, AN UNKNOWN SOFT, FLOPPY STRUCTURE WAS NOTED AT THE TIP OF THE CATHETER UPON REMOVAL FROM THE PATIENT. THE CATHETER WAS INTRODUCED TO THE RIGHT ATRIUM VIA THE GROIN AND WOULD NOT ADVANCE TO THE CORONARY SINUS. UPON REMOVAL, A SOFT, FLOPPY STRUCTURE WAS OBSERVED AT THE TIP OF THE CATHETER. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10777785 ↗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 ↗
Other St. Jude Medical Cardiovascular Division products
All St. Jude Medical Cardiovascular Division devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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