CARDIOBLATE® 4920501Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994334558), received between Jan 6, 2023 and Mar 31, 2023 — classified as 1 death, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPLACEMENT THROUGH STERNOTOMY ON THE (B)(6) 2022. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP AND CARDIOBLATE ABLATION PEN POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2022, THE PATIENT EXPERIENCED SEVERE ANEMIA DUE TO CHRONIC AND ACUTE BLOOD LOSS FROM AN UPPER GI BLEED. THE PATIENT WAS HOSPITALIZED ON SAME DATE, AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2022. LABS PERFORMED DAILY SHOWED LOW HEMOGLOBIN AND HEMATOCRIT. EGD WAS PERFORMED, 5 UNITS OF PACKED RED BLOOD CELLS WAS TRANSFUSED, AND COUMADIN WAS HELD. THE PATIENT WAS DISCHARGED HOME AND GIVEN PROTONIX. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2022. THE DEATH WAS CATEGORIZED AS A NON-CARDIAC DEATH. THE ADVERSE EVENT WAS ASSESSED BY THE SITE AS NOT RELATED TO THE CONCOMITANT PROCEDURE OR THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICES. THE CLINICAL EVENTS COMMITTEE (CEC) ASSESSED THE ADVERSE EVENT AS NOT RELATED TO THE CONCOMITANT PROCEDURE OR THE STUD

  Patient problems: Anemia

  MAUDE report 16654106 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR, TRICUSPID VALVE REPAIR, AND CORONARY ARTERY BYPASS GRAFTING (CABG) (NUMBER OF ANASTOMOSES, FOUR) THROUGH STERNOTOMY ON THE (B)(6) 2019. ON THE DAY OF THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP AND CARDIOBLATE MAPS POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY OVER SEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS ACHIEVED AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2020 THE PATIENT EXPERIENCED NON-SUSTAINED VENTRICULAR TACHYCARDIA. SIX EPISODES WERE REPORTED ON THE HOLTER MONITOR REPORT. THE PATIENT STATUS WAS RECOVERED/RESOLVED ON THE (B)(6) 2020. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, UNLIKELY RELATED TO ALL OF THE STUDY DEVICES AND POSSIBLY RELATED TO THE STUDY PROCEDURE. THE SITE PROVIDED THE FOLLOWING RATIONALE FOR RELATING THE ADVERSE EVENT TO THE CONCOMITANT AND STUDY PROCEDURES; CANNOT RULE OUT, IT¿S AN ARRHYTHMIA.

  Patient problems: Tachycardia

  MAUDE report 16112680 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR, TRICUSPID VALVE REPAIR, AND CORONARY ARTERY BYPASS GRAFTING (CABG) (NUMBER OF ANASTOMOSES, FOUR) THROUGH STERNOTOMY ON THE (B)(6) 2019. ON THE DAY OF THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP AND CARDIOBLATE MAPS POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY OVER SEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS ACHIEVED AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2020 THE PATIENT EXPERIENCED VENTRICULAR PREMATURE COMPLEXES (VPCS). THE PATIENT HAD 1492 VPCS IN 24 HOURS AND MORE THAN 30 IN AN HOUR WERE NOTED ON THE HOLTER MONITOR REPORT. NO SYMPTOMS WERE REPORTED BY THE PATIENT. THE PATIENT STATUS WAS RECOVERED/RESOLVED ON THE (B)(6) 2020. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, UNLIKELY RELATED TO THE STUDY DEVICES AND POSSIBLY RELATED TO THE STUDY PROCEDURE. THE SITE PROVIDED THE FOLLOWING RATIONALE FOR RELATING THE ADVERSE EVENT TO THE CONCOMITANT AND STUDY PROCEDURES; ARRHYTHMIA CANNOT BE RULED OUT, HARD TO KNOW PER PRINCIPLE INVESTIGATOR.

  Patient problems: Arrhythmia

  MAUDE report 16111090 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AORTIC VALVE REPLACEMENT, RECONSTRUCTION OF ASCENDING AORTA A WITH 28MM INTERPOSITION GRAFT AND CORONARY ARTERY BYPASS GRAFTING (CABG) (NUMBER OF ANASTOMOSIS, 1) THROUGH STERNOTOMY ON THE (B)(6) 2021. ON THE DAY OF THE PROCEDURE ((B)(6) 2021) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, A CARDIOBLATE BP2 CLAMP AND A CARDIOBLATE MAPS PEN POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND OVERSEWN. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT PERFORMED AS THE PULMONARY VEINS COULD NOT BE ACCESSED.   ON (B)(6) 2022 THE PATIENT EXPERIENCED NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE PATIENT HAD ONE EPISODE ON THE SIX MONTHS HOLTER MONITOR REPORT. THE PATIENT STATUS WAS RECOVERED/RESOLVED ON (B)(6) 2022. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT AND STUDY PROCEDURES AND UNLIKELY RELATED TO THE STUDY DEVICES. THE SITE PROVIDED THE FOLLOWING RATIONALE FOR RELATING THE ADVERSE EVENT TO THE CONCOMITANT PROCEDURE: ARRHYTHMIA, HARD TO KNOW IF RELATED OR NOT, CANNOT BE RULED OUT. THE SITE PROVIDED THE FOLLOWING

  Patient problems: Tachycardia

  MAUDE report 16110955 ↗