TactiCath™ A-TCSE-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067027702), received between Aug 6, 2018 and Jun 16, 2025 — classified as 8 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF ARRHYTHMIA IN AN ARTICLE TITLED, "CLINICAL INSIGHTS INTO THE ROLE OF BEPRIDIL IN RECURRENCE PREVENTION AFTER ABLATION OF PERSISTENT ATRIAL FIBRILLATION"; MOYURU HIRATA MD1, 2025;41:E70083, HTTPS://DOI.ORG/10.1002/JOA3.70083. THIS RETROSPECTIVE STUDY INCLUDED 232 CONSECUTIVE PERAF PATIENTS WHO UNDERWENT AF ABLATION BETWEEN 2014 AND 2019. AMONG THEM, 162 RECEIVED BEPRIDIL FOR 3 MONTHS POST-ABLATION (BEPRIDIL GROUP), WHILE 70 RECEIVED NO ANTIARRHYTHMIC DRUGS (NO-AADS GROUP). BASELINE CHARACTERISTICS, PROCEDURAL DETAILS, AND OUTCOMES WERE COMPARED. KAPLAN¿MEIER ANALYSIS AND COX REGRESSION MODELS WERE USED TO EVALUATE AF/ATRIAL TACHYCARDIA (AT) RECURRENCE, WITH BEPRIDIL USE TREATED AS A TIME-DEPENDENT COVARIABLE. THERE WERE 3 EVENTS OF CARDIAC TAMPONADE, 3 EVENTS OF SINUS NODE DYSFUNCTION, 1 EVENT OF PHRENIC NERVE PALSY, 1 EVENT OF MAJOR BLEEDING, AND 1 EVENT OF SICK SINUS SYNDROME.

  Patient problems: Arrhythmia; Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding; Nerve Damage

  MAUDE report 22216674 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURING REF: 3008452825-2023-00275. AT THE END OF AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC TAMPONADE WAS OBSERVED DURING RF IN THE LEFT PULMONARY VEINS WHICH REQUIRED DRAINAGE. DURING GENERAL ANESTHESIA THERE WAS LOW BLOOD PRESSURE FOR A PERIOD OF 15 MINUTES. THERE WERE NO ISSUES WHILE USING THE CATHETER. IT WAS POSSIBLE THAT A COMPLICATED TRANSSEPTAL ACCESS CAUSED IT. THE TAMPONADE WAS DIAGNOSED USING VIA AN ECHOCARDIOGRAM AND FLUOROSCOPY. A PERICARDIOCENTESIS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Cardiac Perforation

  MAUDE report 17204538 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SINO-ATRIAL BLOCK HAPPENED AFTER AN ATRIAL TACHYCARDIA ABLATION IN THE RIGHT ATRIUM.

  Patient problems: Heart Block

  MAUDE report 14879003 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE PROCEDURE, A BLOOD CLOT WAS NOTED ON THE TIP OF THE CATHETER. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14718016 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED IN THE RIGHT VENTRICLE. THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED AN EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 14697755 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, AN AORTIC DISSECTION OCCURRED. DURING THE PROCEDURE, THE PATIENT¿S MENTAL STATE CHANGED DESPITE NO CHANGE IN ANESTHESIA LEVELS. THE VENTRICULAR ACCESS WAS DIFFICULT TO ACHIEVE VIA THE RETROGRADE APPROACH (THROUGH THE AORTA). THE PATIENT HAD PREVIOUS AORTIC VALVE REPAIR AND HAD TORTUOUS AORTIC ANATOMY. IT WAS INDICATED AN EMBOLIZATION COULD HAVE CAUSED A STROKE, AND THE CASE WAS TERMINATED. A STROKE WAS NEVER CONFIRMED. A CT SCAN WAS ADMINISTERED AND A DISSECTED AORTA WAS DIAGNOSED, NEAR THE STENOSED AREA OF THE AORTIC ARCH. THE PATIENT WAS TO BE FOLLOWED AT ANOTHER FACILITY AND A STENT WAS IMPLANTED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 9903859 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A SUPRAVENTRICULAR TACHYCARDIA ABLATION, A PERICARDIAL EFFUSION OCCURRED. THE ABLATION PROCEDURE WAS FOR A CONCEALED LEFT LATERAL BYPASS TRACT. TRANSSEPTAL ACCESS WAS OBTAINED AND ABLATION WAS PERFORMED SUCCESSFULLY WHICH ELIMINATED THE LATERAL BYPASS TRACT. POST PROCEDURE, THE PATIENT WAS HYPOTENSIVE. A PERICARDIAL EFFUSION WAS OBSERVED ON FLUOROSCOPY AND AN ECHOCARDIOGRAM WAS USED TO CONFIRM THE EFFUSION. NO INTERVENTION WAS NEEDED TO TREAT THE EFFUSION. THE PHYSICIAN BELIEVED THE PERICARDIAL EFFUSION WAS DUE TO ABLATING AT 50 WATTS. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8513769 ↗
• InjuryAug 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER NUMBER: 2030404-2018-00055, 3008452825-2018-00265. AT THE END OF THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER ISOLATING THE VEINS 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 7755374 ↗