TactiCath™ A-TCSE-DFRecalls & reported problems

Summary

The FDA's MAUDE database contains 923 adverse event reports that list this exact device (DI 05415067027641), received between Jun 25, 2018 and Aug 19, 2026 — classified as 23 deaths, 453 injuries, 447 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (184 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 24, 2022Terminated

   Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

   Z-0956-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 923 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Optical Problem

  During a Paroxysmal Atrial Fibrillation procedure, a delay of approximately 1 hour occurred when pressure readings were not displayed on the system. The TactiCath Catheter was exchanged; however, the issue persisted. Multiple system and equipment restarts were subsequently performed. Following an additional restart, pressure readings became available for both TactiCath Catheters, but the initial catheter continued to demonstrate intermittent pressure display readings. The procedure was completed without adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323360 ↗
• MalfunctionApr 7, 2026Use of Device Problem; Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF AN EXPIRED CATHETER USED DURING THE PROCEDURE. DURING THE AF PROCEDURE, AN EXPIRED CATHETER WAS USED. THE CATHETER WAS NOT VISUALIZED AND THE LSI PARAMETERS WERE NOT DISPLAYED. ALTHOUGH THE CATHETER ITSELF APPEARED ON THE SCREEN, THE WINDOW DISPLAYING THE CATHETER-RELATED CONTACT FORCE AND LSI PARAMETERS APPEARED BUT DID NOT SHOW ANY DATA. THE METAL BASELINE WAS SET, AS WAS THE DISTORTION. THE SIGNALS FROM THE CATHETER ELECTRODES DID NOT APPEAR ON EITHER THE ENSITE SYSTEM OR THE NON-ABBOTT (PRUCKA) EP SYSTEM. AS A PRECAUTION, THE CONNECTIONS BETWEEN THE TACTISYS AND THE TACTICATH CATHETER WERE CHECKED; HOWEVER, THE ISSUE COULD NOT BE IDENTIFIED. THE CONNECTION BETWEEN THE TACTISYS SYSTEM AND THE GENERATOR WAS ALSO CHECKED, ALONG WITH ALL AMPLIFIER CONNECTIONS. THE CATHETER WAS USED AS DESCRIBED IN THE IFU. ULTIMATELY, THE ISSUE WAS RESOLVED BY USING A NEWLY OPENED TACTIFLEX CATHETER, WHICH IMMEDIATELY DISPLAYED VALUES ON THE ICON AFTER INSERTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803596 ↗
• DeathMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AF) PROCEDURE ON (B)(6) 2026. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT THE HOSPITAL ON (B)(6) 2026 WITH CHEST PAIN, FEVER, AND SKIN MOTTLING. THE PATIENT DISPLAYED AN ALTERED CONSCIOUSNESS STATE WITH GLASGOW SCORE OF 11. A CT SCAN SHOWED MEDIASTINAL AIR BUBBLES AND INTRA CARDIAC AIR BUBBLES WHICH LEAD TO AN ATRIOESOPHAGEAL FISTULA. THE FISTULA WAS LOCATED POSTERIOR TO THE LEFT SUPERIOR PULMONARY VEIN OSTIUM. CARDIAC SURGERY WAS PERFORMED WHERE A PATCH WAS PLACED. THE PATIENT DIED ON (B)(6) 2026. A NON-ABBOTT TEMPERATURE PROBE (PROACT REF. (B)(4)) HAD BEEN USED DURING THE AF PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE FISTULA. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Perforation of Esophagus

  MAUDE report 24743950 ↗
• InjuryMar 9, 2026Patient Device Interaction Problem

  AN BAIFU, ZHANG XUELIAN, BAI MEI, ET AL. EFFECT OF USING IMPEDANCE CHANGE MONITORING TO ASSIST LESION INDEX¿GUIDED HIGH-POWER ABLATION FOR ATRIAL FIBRILLATION. CHINESE JOURNAL OF GERIATRICS, 2025, 45(08): 1793¿1796. A TOTAL OF 50 PATIENTS WHO UNDERWENT HIGH-POWER (40¿45 W) ATRIAL FIBRILLATION ABLATION GUIDED BY THE LESION SIZE INDEX (LSI) WERE ENROLLED AS THE CONTROL GROUP. ANOTHER 50 NEWLY SELECTED PATIENTS WHO MET THE INDICATIONS FOR RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION WERE INCLUDED AS THE STUDY GROUP. ABLATION IN THE STUDY GROUP WAS INITIATED USING THE SAME HIGH-POWER SETTINGS AS THE CONTROL GROUP. DURING THE PROCEDURE, THE BASELINE IMPEDANCE AND IMPEDANCE DROP AT EACH ABLATION POINT WERE MONITORED. WHEN THE LSI REACHED THE TARGET VALUE BUT THE IMPEDANCE DROP WAS <10%, THE ABLATION PARAMETERS AND THE CONTACT FORCE OF THE ABLATION CATHETER WERE ADJUSTED, FOLLOWED BY ADDITIONAL ABLATION. IF AN IMPEDANCE RISE OCCURRED DURING ABLATION OR IF THE IMPEDANCE DROPPED BY >15% WITHIN THE FIRST 5 SECONDS, THE ABLATION WAS IMMEDIATELY TERMINATED. 4 STEAM POPS AND 1 STEAM POP FOLLOWED BY A PERICARDIAL EFFUSION REQUIRING A PERICARDIOCENTESIS WERE REPORTED.

  Patient problems: Cardiac Perforation

  MAUDE report 24547008 ↗
• MalfunctionMar 4, 2026Communication or Transmission Problem

  DURING THE PVC PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE ABLATION CATHETER WAS NOT LOCATING ON THE ENSITE MAPPING SYSTEM UPON CONNECTION. ENSITE PROMPTED THAT THE CATHETER HAD A SENSOR ISSUE IN THE PORT. THE TACTISYS WAS REPLACED, THE SE EXTENSION WAS BYPASSED, AND THE CATHETER WAS DIRECTLY PLUGGED INTO ENSITE MAPPING AMPLIFIER, 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 24510300 ↗
• MalfunctionFeb 26, 2026Optical Problem

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP WITH PROTRUDING COMPONENTS DURING INVESTIGATION. DURING THE SVT PROCEDURE, IT WAS NOTED THAT THE CONTACT FORCE WAS NOT DISPLAYED ACCURATELY. THE CONTACT FORCE WAS RESET; HOWEVER, THE ISSUE PERSISTED. THE ENSITE SYSTEM DISPLAYED AN ERROR MESSAGE STATING THAT NO CONTACT FORCE WAS AVAILABLE. THE CONNECTIONS WERE CHECKED AND THE TACTISYS WAS RESTARTED WITH NO RESOLUTION. 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 24457873 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THIS REPORT INCLUDES UPDATED DEVICE BATCH/LOT NUMBER, MODEL, AND ASSOCIATED MANUFACTURING INFORMATION.

  Patient problems: Cardiac Perforation

  MAUDE report 24359233 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AFTER CONFIRMING THE PULMONARY VEINS AND POSTERIOR WALL WERE BLOCKED, AN ELEVATED ST SEGMENT WAS OBSERVED WHEN GOING BACK ON 12 ECG SCREEN ON THE EP RECORDING SYSTEM. THIS APPEARED WHEN BOTH THE ABLATION CATHETER AND THE MAPPING CATHETER DID NOT MOVE. THE ARRHYTHMIA LASTED FOR LESS THAN 5 MINUTES AND RESOLVED PROGRESSIVELY ON ITS OWN WITHOUT ANY INTERVENTION. THE CAUSE OF THE ARRHYTHMIA IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Arrhythmia

  MAUDE report 24058800 ↗
• InjuryDec 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A LEFT ATRIAL FLUTTER (FA) ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED REQUIRING SURGERY. AN AUDIBLE ¿POP¿ OCCURRED WHILE DELIVERING RADIOFREQUENCY ENERGY AT THE RIDGE REGION OF THE LEFT ATRIUM. IMMEDIATELY AFTER THE EVENT, THE PATIENT DEVELOPED SIGNS CONSISTENT WITH ACUTE CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS ATTEMPTED, BUT DUE TO THE SEVERITY OF THE EFFUSION AND HEMODYNAMIC INSTABILITY, THE SURGICAL TEAM WAS ACTIVATED. BECAUSE OF THIS COMPLICATION, THE ABLATION PROCEDURE COULD NOT BE COMPLETED. THE PATIENT WAS TAKEN FOR URGENT CARDIAC SURGERY, WHERE DEFINITIVE MANAGEMENT OF THE COMPLICATION WAS PERFORMED. FOLLOWING THE SURGICAL INTERVENTION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR POSTOPERATIVE MONITORING.

  Patient problems: Cardiac Perforation

  MAUDE report 23885952 ↗
• MalfunctionDec 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A RIGHT SIDED AFL ABLATION PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE CATHETER RESULTING IN A DELAY. AFTER CONNECTING THE CATHETER TO THE ENSITE X SYSTEM, THE CATHETER WAS NOT VISIBLE IN THE NAVX SYSTEM. THREE ATTEMPTS WERE MADE TO DISCONNECT THE CATHETER, DELETE ABL FROM NAVX CONFIGURATION AND RECONNECT AND TURN OFF AND RESTART THE TACTISYS, DISPLAY WORKSTATION, AND AMPLIFIER. THE TACTISYS CABLE WAS ALSO EXCHANGED, WITH NO RESOLUTION. THE CATHETER WAS EXCHANGED AND THE ISSUE AS RESOLVED. THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879292 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER TIP WITH A PROTRUDING COMPONENT DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832029 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE WITH A PROTRUDING COMPONENT FOUND IN THE CATHETER TIP DURING INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23781335 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. AFTER ISOLATING BOTH PULMONARY VEINS, AN HD GRID WAS PLACED INSIDE EACH VEIN, AND BIDIRECTIONAL BLOCK WAS BEING CONFIRMED BY PACING WHEN A DROP IN BLOOD PRESSURE WAS OBSERVED. A CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC AND INTRACARDIAC ECHOCARDIOGRAPHY, AND ADRENALINE WAS ADMINISTERED. AFTER SOME TIME, BLOOD PRESSURE STABILIZED. ALTHOUGH THE ACCUMULATION OF BLOOD WAS MINIMAL, A PERICARDIOCENTESIS WAS PERFORMED. A CT SCAN WAS THEN DONE, AND THE PATIENT WAS MONITORED IN THE ICU. THE PATIENT REMAINED STABLE. THE PHYSICIAN IS NOT CERTAIN WHAT CAUSED THE EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 23708029 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED AFTER RF ABLATION LESIONS IN THE RVOT AND LVOT THAT REQUIRED PERICARDIOCENTESIS. AT THE START OF THE PROCEDURE, A DIAGNOSTIC CATHETER WAS USED TO CREATE RV GEOMETRY AND COLLECT MAPPING DATA IN THE RV AND RVOT. A SITE OF INTEREST WAS IDENTIFIED, AND THE DIAGNOSTIC CATHETER WAS REMOVED FROM THE PATIENT. THE ABLATION CATHETER WAS THEN ADVANCED INTO THE RIGHT ATRIUM, AND CONTACT FORCE WAS ZEROED. RF LESIONS WERE DELIVERED AT THE SITE OF INTEREST IN THE RVOT. THE ABLATION CATHETER WAS REMOVED FROM THE RVOT, RETROGRADE AORTIC ACCESS WAS OBTAINED, AND THE ABLATION CATHETER WAS ADVANCED INTO THE LVOT WHERE GEOMETRY AND MAPPING DATA WERE COLLECTED AND RF LESIONS WERE DELIVERED. THE ABLATION CATHETER WAS REMOVED FROM THE PATIENT AND PLACED BACK INTO THE RVOT. THE ABLATION CATHETER WAS REMOVED FROM THE PATIENT AND THE DIAGNOSTIC CATHETER WAS ADVANCED INTO THE RVOT WHERE MORE MAPPING AND GEOMETRY DATA WERE COLLECTED. A CONTACT FORCE ERROR MESSAGE DISPLAYED THAT REQUIRED THE ABLATION CATHETER TO BE REPLACED WITH A NEW ABLATION CATHETER. THE NEW ABLATION CATHETER WAS USED FOR THE REST OF THE PROCEDURE, AND MOR

  Patient problems: Cardiac Perforation

  MAUDE report 23688673 ↗
• MalfunctionNov 29, 2025Optical Problem; Optical Problem

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, A CONTACT FORCE ISSUE OCCURRED WITH THE TACTICATH ABLATION CATHETER RESULTING IN A DELAY. CONTACT FORCE WAS DISPLAYED AS EXPECTED INITIALLY. AFTER RF WAS APPLIED, THE CATHETER WAS PULLED OUT TO OBSERVE FOR TEN MINUTES. HOWEVER, WHEN THE CATHETER WAS REINSERTED INTO THE RIGHT ATRIUM AGAIN TO CONSOLIDATE ABLATION, IT WAS NOTED THAT THE ENSITE MAPPING SYSTEM DISPLAYED AN ERROR MESSAGE STATING: "NO CONTACT FORCE INFORMATION AVAILABLE". THE CONNECTIONS WERE CHECKED, THE TACTISYS AND MAPPING SYSTEM WERE RESTARTED, BUT THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS THEN EXCHANGED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675643 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A COMMON FLUTTER ABLATION PROCEDURE, THE POST-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM WAS NORMAL. IN THE RECOVERY ROOM, THE PATIENT COMPLAINED OF CHEST PAIN, SO A TRANSTHORACIC ECHOCARDIOGRAM WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 500 ML WAS DRAINED AND THE PATIENT STABILIZED. IT WAS LATER NOTED THAT ONE LESION NEAR THE INFERIOR VENA CAVA SHOWED A RISE IN IMPEDANCE (FROM 90 TO 120 OHMS), WHICH MAY EXPLAIN THE OCCURRENCE OF THE EFFUSION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23585878 ↗
• MalfunctionNov 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS NOT BEING RECOGNIZED. THE DEVICE WOULD POPULATE ON ENSITE BUT WOULD NOT SHOW AS CONNECTED ON AMPERE. THE CABLE BETWEEN THE TACTISYS AND AMPERE WAS REPLACED, BUT THE ISSUE PERSISTED. BOTH THE AMPERE AND TACTISYS WERE REPLACED AS WELL, BUT THE ISSUE REMAINED. THE CATHETER WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577432 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A SLOW PATHWAY MODIFICATION PROCEDURE FOR TYPICAL AVNRT, TRANSIENT HEART BLOCK OCCURRED THAT RECOVERED BY THE TIME THE PROCEDURE WAS FINISHED. WHEN THE TACTI CATH SE ABLATION CATHETER WAS ADVANCED TOWARD A MANUAL 3D HIS LESION IN THE RIGHT ATRIUM TO CHECK FOR HIS SIGNAL FOLLOWING DELIVERY OF RF LESIONS FOR SLOW PATHWAY MODIFICATION, THE PATIENT ENTERED COMPLETE HEART BLOCK WITH A JUNCTIONAL ESCAPE. THE COMPLETE HEART BLOCK WENT UNNOTICED IN THE PROCEDURE FOR ABOUT 1 MINUTE. BEFORE THE COMPLETE HEART BLOCK WAS NOTED, TWO ADDITIONAL RF LESIONS WERE DELIVERED IN THE SLOW PATHWAY AREA, AND SLOW JUNCTIONAL RHYTHMS WERE OBSERVED DURING ABLATION. AFTER THE FINAL LESION, THE COMPLETE HEART BLOCK WAS NOTED BY THE PHYSICIAN. THE TACTI CATH SE ABLATION CATHETER WAS REMOVED FROM THE SLOW PATHWAY AREA AND PLACED INTO THE IVC TO SEE IF AV SYNCHRONY WOULD RETURN. AFTER A FEW MINUTES, THE PATIENT ENTERED SECOND DEGREE 2:1 AV BLOCK. THE PHYSICIAN THEN ADMINISTERED ISUPREL. AFTER THE ISUPREL WAS STOPPED, THE PATIENT WAS STILL EXPERIENCING 2:1 AV BLOCK. AT THIS TIME, THE PHYSICIAN REMOVED ALL CATHETERS FROM THE BODY AND DECLARED THE PROCEDURE TO BE OVER. AS ANESTHESIA BEGAN WAKING UP THE PATIE

  Patient problems: Heart Block

  MAUDE report 23556064 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A VENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS. ONCE THE PROCEDURE HAD FINISHED, WHILE STILL IN THE PROCEDURE ROOM, THE PATIENT FELT SICK AND AN ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION WITHOUT CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS DONE AND THE PATIENT WAS RECOVERING. IT IS ALLEGED THAT HIGH CONTACT FORCES OF 50 GRAMS THAT OCCURRED DURING ABLATION IN THE RVOT COULD HAVE BEEN THE CAUSE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 23380596 ↗
• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RIGHT ACCESSORY PATHWAY PROCEDURE, A HEART BLOCK OCCURRED REQUIRED A PACEMAKER IMPLANTATION. DURING ABLATION THE CATHETER WAS IN THE CORRECT LOCATION FOR APPLICATION, HOWEVER IT WAS NOT NOTICED WHEN THE CATHETER MOVED OUT OF POSITION AND APPLIED ABLATION IN THE REGION OF THE PATIENT'S NATURAL PACEMAKER (HIS) AND CONSEQUENTLY THE PATIENT REQUIRED HAVING AN ARTIFICIAL PACEMAKER PLACED.

  Patient problems: Heart Block

  MAUDE report 23334117 ↗
• InjuryOct 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FLUTTER/FIBRILLATION ABLATION AN EFFUSION OCCURRED THAT REQUIRED A PERICARDIOCENTESIS. WHILE WORKING ON THE CTI LINE, THE PHYSICIAN REPORTS NOTING A POSSIBLE STEAM POP. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED BY ICE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE ICU FOR OBSERVATION.

  Patient problems: Cardiac Perforation

  MAUDE report 23332073 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE PERFORMED ON (B)(6) 2024 THE PATIENT DEVELOPED COMPLICATIONS DUE TO AN ESOPHAGEAL FISTULA. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Perforation of Esophagus

  MAUDE report 23251803 ↗
• DeathOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE PERFORMED ON (B)(6) 2025, THE PATIENT DEVELOPED AN ESOPHAGEAL FISTULA AND EXPIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO NOTED PERFORMANCE ISSUES.

  Patient problems: Perforation of Esophagus

  MAUDE report 23251797 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. DURING THE PROCEDURE, WHEN JUST STARTING TO ABLATE, THE PATIENT BECAME HYPOTENSIVE AND A TRANSTHORACIC ULTRASOUND WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 23084196 ↗
• DeathSep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE MONTH FOLLOWING ABLATION PROCEDURE, PATIENT DEVELOPED AN ATRIO-ESOPHAGUS FISTULA. THE ORIGINAL ABLATION PROCEDURE WAS IN (B)(6) 2025 AND THE DIAGNOSIS OCCURRED IN (B)(6) 2025. THE PATIENT DEVELOPED A FEVER. ECHOCARDIOGRAM SHOWED SOME SMALL BUBBLES. CT SCAN SHOWED SOME ABNORMALITIES BETWEEN THE ESOPHAGUS AND THE LEFT ATRIUM. A PATCH WAS APPLIED ON BOTH THE ESOPHAGUS AND THE LEFT ATRIUM. HOWEVER, THE PATIENT IS NOW DECEASED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Perforation of Esophagus

  MAUDE report 23018181 ↗