Volt™ PFA Sensor Enabled™ A-VOLT-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 05415067053022), received between Jan 26, 2026 and Sep 28, 2026 — classified as 2 deaths, 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (12 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924982 ↗
• OtherSep 28, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924939 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  After a pulsed field ablation atrial fibrillation procedure using a Volt catheter, Advisor HD Grid X catheter, Agilis 13F sheath, EnSite X, and a non-Abbott (Boston Scientific VersaCross) wire, the patient experienced a stroke. The patient was found unresponsive four days following the procedure. Patient was noted to be cyanotic, with cold extremities and right sided hemiparesis. The patient was outside of the TPA thrombectomy window and was transferred to a neurological ICU. A head CT showed large left MCA territory infarct, complete loss of grey/white definition, and a midline shift. Additionally, the patient was noted to have such pronounced brain swelling that most treatments were not pursued. Prior to the procedure, a TEE was performed to rule out thrombus as the patient had missed 1-2 does of their Pradaxa prescription. It was noted when the ICE catheter was advanced that a baseline effusion was present. The transseptal puncture was then performed using a non-Abbott (Boston Scientific VersaCross) wire and sheath. Following transseptal puncture, the non-Abbott wire and sheath were replaced with an Agilis 13F sheath. It was noted that the effusion was still at baseline. The Adv

  Patient problems: Stroke/CVA

  MAUDE report 50902672 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868798 ↗
• DeathSep 18, 2026Failure to Deliver Energy; High impedance

  During a Volt PVI procedure, a pericardial tamponade requiring sternotomy resulting in death was noted. Transseptal access was obtained using an Agilis sheath and BRK needle. The LSPV was accessed with a non-Abbott (Merit) InQwire guidewire, with the Volt catheter being advanced to the ostium of the LSPV. The Volt balloon was inflated with 10 cc of saline and contrast medium, and respiratory compensation for catheter movement was performed. The baseline calibration was conducted by rotating the balloon and moving it forward and backward. The first PFA application was initiated, reach 90% completion and the system automatically aborted the application with the error message stating "PFA Generator fault - Therapy pathway resistance exceeded the acceptable limit". The catheter was disconnected and reconnected, confirmed to be fully inflated and confirmed the guidewire was positioned within the pulmonary vein and not in contact with the splines. Baseline was repeated and the second application was delivered 100% with auto marks. Two subsequent applications were automatically aborted by the system. The generator was restarted, the PFA unified cabled and PFA gen connect cables were disco

  Patient problems: Arrhythmia; Cardiac Perforation

  MAUDE report 50818987 ↗
• MalfunctionSep 17, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808696 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808522 ↗
• MalfunctionSep 15, 2026Difficult to Remove

  During a PFA/AF procedure, the procedure was abandoned. An attempt was made to access the right pulmonary veins. The patient's anatomy was very complex and during the maneuvers, the Agilis stopped deflecting to one side as expected. The procedure was attempted to be continued with the same Agilis, rotating the Agilis handle a lot until the Volt catheter was stuck inside the Agilis. The Volt catheter could not be removed, the balloon couldn't be deflated either. The multiple turns of the Agilis were reversed on the Agilis dial, and the Volt balloon was able to be deflated, thought the Volt catheter still could not be removed. Both the Volt and Agilis were removed from the patient. No other intervention was needed. The procedure was canceled and all devices were removed from the patient. There were no adverse consequences to the patient. The patient remained in the ICU for a day just for monitoring and was released with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777693 ↗
• MalfunctionSep 15, 2026Communication or Transmission Problem

  During the PFA procedure, there was a procedural delay. The catheter could not connect to the current generator and amplifier simultaneously. When the amplifier was connected, the catheter was not recognized by the system. A complete system restart was performed, and the recommended power-up sequence was performed five times. The EnSite case was exited and re-entered, the connection cables were exchanged, but the issue was not resolved. The catheter was exchanged, and the procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773255 ↗
• MalfunctionSep 8, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673578 ↗
• MalfunctionSep 8, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673555 ↗
• MalfunctionSep 8, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673528 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670937 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  During a PFA/AF procedure, heart block occurred after a vagal response following the first PFA application. Prior to the first PFA application in the LSPV, atropine was not administered. After the first application, the patient had a vagal response that progressed to complete heart block. The PFA application was stopped due to an inability to R-wave gate. Pacing was attempted with the CS catheter without capture. The CS catheter was then repositioned to the RV and pacing was successfully achieved. After about 2 minutes of RV pacing, the patient's intrinsic rhythm returned. A quadripolar catheter was placed in the RV for backup pacing and atropine was administered. During the second PFA application in the LSPV, the patient developed complete heart block again. RV pacing was initiated, and PFA application was completed. Complete heart block also occurred during the third LSPV application and again during the first PFA application in the LIPV, requiring pacing each time. The procedure was completed. The patient remains stable. No other intervention was needed after. The physician alleges that the Volt PFA applications were the cause of the heart block. There were no performance issues

  Patient problems: Heart Block

  MAUDE report 50455400 ↗
• MalfunctionAug 24, 2026Fluid/Blood Leak

  During a PFA/PVI procedure, it was noted that fluid was leaking from the center lumen of the Volt catheter. The Volt catheter was prepared in accordance to the IFU. During the PVI ablations, three of the pulmonary veins were successfully isolated prior to cannulation of the RIPV, which was the final vein. The balloon was deflated to facilitate RIPV cannulation. No blood was noted in the deflation syringe. The RIPV was successfully isolated and the posterior wall ablation was completed. At the conclusion of the procedure, the Volt catheter was removed from the sheath. Blood was noted in the syringe to deflate the balloon. After the Volt catheter was fully withdrawn, blood was also noted in the balloon. The balloon was then reinflated outside the patient for inspection. Fluid was noted to be dripping from the center lumen of the catheter. No visible puncture, tear, or defect was identified on any portion of the balloon. The procedure was completed with no adverse consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412653 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  DURING A PVI PROCEDURE, ONE OF THE BALLOON SPLINES BROKE OFF AT THE DISTAL CONNECTION. REGULAR ACCESS WAS OBTAINED, TRANSSEPTAL WAS PERFORMED, MAPPING WAS DONE, VOLT CATHETER WAS PREPPED, BASELINE DONE, AND SUCCESSFUL THERAPY DELIVERY WAS DONE ON THE LSPV. THE VOLT WAS NAVIGATED INTO THE LIPV WHEN THERAPY WAS ABORTED BY THE CURRENT GENERATOR WITH THE ERROR: "SHORT CIRCUIT ON THERAPY PATH". AFTER SHORT TROUBLESHOOTING ON CURRENT ECG PATCHES, BASELINE, RECONNECTING THE CATHETER THERE WAS NO RESOLUTION. THE CATHETER WAS REMOVED FOR INSPECTION WHICH REVEALED THAT ONE OF THE SPLINES OF THE BALLON BROKE OFF THE CATHETER AT THE DISTAL CONNECTION. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25393123 ↗
• MalfunctionMay 29, 2026Fracture

  THIS REPORT IS TO ADVISE ON A FRACTURED SPLINE WITH SHARP EDGES FOUND DURING INVESTIGATION. DURING THE AF PROCEDURE, IT WAS NOTED THAT BASELINE COULD NOT BE OBTAINED ON ELECTRODES 5 AND 6. THE PINS WERE RE-PLUGGED, AND BASELINE WAS ATTEMPTED TO BE TAKEN AT DIFFERENT HEART LOCATIONS, WITH NO RESOLUTION. THE PROCEDURE WAS CONTINUED WITHOUT USING ELECTRODES 5 AND 6. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333340 ↗
• MalfunctionMay 20, 2026Communication or Transmission Problem

  DURING THE PULSED FIELD ABLATION PULMONARY VEIN ISOLATION PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A MAGNETIC SENSOR ISSUE. THE CATHETER WAS RECOGNIZED BY THE ENSITE X SYSTEM, BUT AN ERROR APPEARED SAYING "CATHETER IN PORT 7 HAS A MAGNETIC SENSOR ISSUE. CHECK CONNECTIONS AND CONSIDER REPLACING THE CATHETER OR ITS CABLE" AND THE CATHETER WAS NOT VISUALIZED. THE CATHETER WAS RECONNECTED, THE DWS, AMPLIFIER, AND CURRENT GENERATOR WERE REBOOTED WITH NO RESOLUTION. EVERYTHING WAS RECONNECTED AGAIN AND THE SAME TROUBLESHOOTING WAS PERFORMED AGAIN. A DIFFERENT PORT ON THE AMPLIFIER WAS ATTEMPTED WITH NO RESOLUTION. AFTER 12-15REBOOTS AND RECONNECTIONS OF THE ENSITE X DWS, ENSITE X AMPLIFIER, AND CURRENT PFA GENERATOR THE CATHETER WAS FINALLY RECOGNIZED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO VISIBLE DEFECTS NOTED AND NO ISSUES NOTED DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232318 ↗
• MalfunctionMay 20, 2026Communication or Transmission Problem

  DURING THE PFA/PVI PROCEDURE, THERE WAS A PROCEDURAL DELAY DUE TO A MAGNETIC SENSOR ISSUE. THE CATHETER WAS RECOGNIZED BY THE ENSITE X SYSTEM, BUT AN ERROR APPEARED SAYING "CATHETER IN PORT 7 HAS A MAGNETIC SENSOR ISSUE. CHECK CONNECTIONS AND CONSIDER REPLACING THE CATHETER OR ITS CABLE" AND THE CATHETER WAS NOT VISUALIZED. THE CATHETER WAS RECONNECTED, THE DWS, AMPLIFIER, AND CURRENT GENERATOR WERE REBOOTED WITH NO RESOLUTION. EVERYTHING WAS RECONNECTED AGAIN AND THE SAME TROUBLESHOOTING WAS PERFORMED AGAIN. A DIFFERENT PORT ON THE AMPLIFIER WAS ATTEMPTED WITH NO RESOLUTION. AFTER 5-6 REBOOTS AND RECONNECTIONS OF THE ENSITE X DWS, ENSITE X AMPLIFIER, AND CURRENT PFA GENERATOR THE CATHETER WAS FINALLY RECOGNIZED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WERE NO VISIBLE DEFECTS NOTED AND NO ISSUES NOTED DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230878 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  ONE DAY FOLLOWING A PULSED FIELD ABLATION (PFA) PROCEDURE, THE PATIENT REPORTED ABNORMAL VISION. SUBSEQUENT MAGNETIC RESONANCE IMAGING (MRI) CONFIRMED A CEREBROVASCULAR ACCIDENT (CVA), WITH EVIDENCE OF INFARCTION IN THE SUBCORTICAL WHITE MATTER. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED; HOWEVER, NO THERAPEUTIC INTERVENTION WAS UNDERTAKEN FOR THE CVA. PRIOR TO THE ABLATION PROCEDURE, INTRA-ARTERIAL THROMBUS WAS EXCLUDED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE REPORTING PHYSICIAN INDICATED THAT THE ETIOLOGY OF THE CVA MAY BE ATTRIBUTED EITHER TO THE INDEX PROCEDURE OR TO THE PATIENT¿S HISTORY OF ATRIAL FIBRILLATION PERSISTING FOR FIVE DAYS WITHOUT ANTICOAGULATION THERAPY. ADDITIONALLY, AN ARTERIOVENOUS (AV) FISTULA WAS IDENTIFIED BY DUPLEX SONOGRAPHY. MANAGEMENT INCLUDED REPEATED APPLICATIONS OF MANUAL COMPRESSION AND PRESSURE BANDAGING OVER THE SUBSEQUENT DAYS. THE FISTULA WAS NOT ASSOCIATED WITH HEMODYNAMIC COMPROMISE AT ANY POINT. A HEMATOMA AND LOCALIZED PAIN WERE ALSO OBSERVED. THE PHYSICIAN ASSESSED THE AV FISTULA AS LIKELY RELATED TO VASCULAR ACCESS (PUNCTURE-RELATED). NO PERFORMANCE ISSUES WERE IDENTIFIED WITH ANY ABBOTT DEVICES, AND NO UNEXPECTED PROCEDURAL COMPLIC

  Patient problems: Stroke/CVA

  MAUDE report 25218828 ↗
• MalfunctionMay 1, 2026Peeled/Delaminated; Material Separation

  DURING POST-ABLATION MAPPING WITH THE VOLT CATHETER FOLLOWING PFA APPLICATIONS, THE PHYSICIAN OBSERVED A NEW OPAQUE OBJECT ON FLUOROSCOPY THAT HAD NOT BEEN PRESENT EARLIER IN THE PROCEDURE. THE VOLT CATHETER WAS REMOVED FROM THE PATIENT, AND THE OPAQUE OBJECT REMAINED VISIBLE ON FLUOROSCOPY. INSPECTION OF THE CATHETER REVEALED THAT A PORTION OF INSULATION ON ONE OF THE SPLINES HAD BEEN SHEARED, THOUGH STILL PARTIALLY ATTACHED. A NEW SHEATH WAS INTRODUCED, AND THE PHYSICIAN ASPIRATED THE FOREIGN OBJECT FROM THE RIGHT INFERIOR PULMONARY VEIN. THE RETRIEVED MATERIAL WAS IDENTIFIED AS A DETACHED RING ELECTRODE ORIGINATING FROM THE SHAFT OF THE VOLT CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 25059512 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PULSED FIELD ABLATION (PFA) PROCEDURE FOR THE TREATMENT OF ATRIAL FIBRILLATION, A VASOVAGAL RESPONSE AND HEART BLOCK OCCURRED WHICH REQUIRED PACING SUPPORT AS WELL AS A CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. FOLLOWING SUCCESSFUL TRANSSEPTAL ACCESS, THE PFA CATHETER WAS ADVANCED INTO THE LEFT ATRIUM. DELIVERY OF THE INITIAL SET OF ABLATION LESIONS WAS INITIATED WHEN THE PATIENT EXPERIENCED A VAGAL RESPONSE, AND PFA DELIVERY WAS DISCONTINUED. HEART BLOCK WAS OBSERVED SO THE PHYSICIAN REMOVED THE DUO-DECAPOLAR DIAGNOSTIC CATHETER FROM THE CORONARY SINUS AND REPOSITIONED IT IN THE RIGHT VENTRICLE FOR PACING SUPPORT. ABLATION IN THE LEFT ATRIUM WAS COMPLETED. DURING POST-ABLATION MAPPING, WITH THE PFA CATHETER POSITIONED MID-CHAMBER AND THE GUIDEWIRE FULLY RETRACTED, THE PATIENT DEVELOPED HYPOTENSION. INTRACARDIAC ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION SURROUNDING THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN ALLEGES THAT THE CARDIAC PERFORATION OCCURRED DURING DELIVERY OF THE RIGHT-SIDED ABLATION LESIONS AND ATTRIBUTED THE EVENT TO THE DIAGNOSTIC CATHETER. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOT

  Patient problems: Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 24889212 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak; Fracture; Difficult to Remove

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION USING PULSED FIELD ABLATION (PFA), TWO SPLINES WERE NOTED TO HAVE FRACTURED. AT THE END OF THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE RETRACTING THE CATHETER BALLOON INTO THE AGILIS SHEATH. FOLLOWING REMOVAL OF THE VOLT CATHETER, INSPECTION REVEALED THAT TWO SPLINES WERE FRACTURED ON THE DISTAL PORTION OF THE CATHETER. THE PHYSICIAN REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858073 ↗
• MalfunctionApr 10, 2026Difficult to Insert

  DURING THE PULSED FIELD ABLATION PROCEDURE, THERE WAS A PROCEDURAL DELAY. THE VOLT CATHETER COULD NOT BE ADVANCED THROUGH THE SHEATH. THE CATHETER WAS FULLY DEFLATED PRIOR TO ATTEMPTING REMOVAL. NO ISSUES WERE NOTED DURING THE DEFLATION PROCESS. THE LPV AND RSPV WERE ISOLATED, AND FOR THE RIPV THE VOLT CATHETER WAS RETRACTED INTO THE AGILIS SHEATH, THE SHEATH WAS ROTATED TOWARD THE RIPV, AND THE GUIDEWIRE WAS ADVANCED TO POSITION IN THE RIPV. HOWEVER, THE VOLT CATHETER WOULD NOT ADVANCE OUT OF THE SHEATH. THE VOLT CATHETER AND AGILIS SHEATH WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24841737 ↗
• InjuryApr 9, 2026Display or Visual Feedback Problem

  DURING THE PULSED FIELD ABLATION PROCEDURE, AN EFFUSION WAS NOTED. THE VOLT CATHETER DID NOT DISPLAY AS EXPECTED ON ENSITE. THE BALLOON APPEARED OFF AXIS FOR MOST OF THE PROCEDURE. IT ALSO DISPLAYED ANTERIOR TO THE INITIAL ADVISOR HD GRID X GEOMETRY. THE DISPLAY ISSUE WAS MOST OBVIOUS AT THE LIPV WHERE THE CATHETER ALSO DISPLAYED AS UNDERINFLATED. ON ICE, IT WAS CONFIRMED THAT THE CATHETER WAS FULLY INFLATED AND THE BALLOON WAS FULLY INTACT WHEN CHECKED AFTER THE PROCEDURE. THIS ISSUE DID NOT IMPEDE THE ABILITY TO COMPLETE THE PROCEDURE. THERE WERE ALSO WIDE SWINGS IN THE RESPIRATORY AND THE PATIENT HAD A LARGE EFFUSION AT BASELINE. AT THE END OF THE PROCEDURE, THE SHEATH FILTER AND RESPIRATORY COMPENSATION WERE TURNED OFF WITH NO RESOLUTION. BASELINE WAS PERFORMED AGAIN WITH NO RESOLUTION EITHER. THE VOLT CATHETER WAS NOT REPLACED.

  Patient problems: Pericardial Effusion

  MAUDE report 24837688 ↗