CARDIOBLATE® 60831Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885074266022), received between Nov 1, 2019 and Dec 27, 2023 — classified as 7 injuries, 1 malfunction.

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.

• MalfunctionDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF CORONARY ARTERY BYPASS GRAFT (CABG) THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON THE (B)(6) 2023 A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, A CARDIOBLATE MAPS MODEL AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED/EXCISED AND OVERSEWN. LEFT PULMONARY VEIN (LPV) AND THERIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE SUCCESSFULLY ACHIEVED. ON THE (B)(6) 2023 THE PATIENT EXPERIENCED VENTRICULAR PREMATURE CONTRACTIONS (VPCS). THE ERT HOLTER REPORT SHOWED FREQUENT VPCS, MORE THAN THIRTY IN ONE HOUR. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 18396616 ↗
• InjuryMay 9, 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 WITH A 28MM INTERPOSITION GRAFT AND CORONARY ARTERY BYPASS GRAFTING (CABG) (NUMBER OF ANASTOMOSES: 1) THROUGH STERNOTOMY ON (B)(6) 2021. DURING THE PROCEDURE ON (B)(6) 2021 A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP AND CARDIOBLATE MAPS DEVICE POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED/EXCISED AND OVERSEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED, IT WAS STATED THAT CORONARY ARTERY BYPASS (CAB) AFTER MAZE AND THEY WERE UNABLE TO ACCESS THE PULMONARY VEIN (PV). RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED, IT WAS STATED THAT CORONARY ARTERY BYPASS (CAB) AFTER MAZE AND THEY WERE UNABLE TO ACCESS THE PULMONARY VEIN (PV). ON (B)(6) 2023, THE PATIENT EXPERIENCED  NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE PATIENT HAD THREE EPISODES ON THE 12-MONTH HOLTER MONITOR REPORT. THE PATIENT STATUS WAS RECOVERED/RESOLVED ON (B)(6) 2023. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE, UNLIKELY RELATED TO THE CRYOFLEX PROBE, CRYO

  Patient problems: Tachycardia

  MAUDE report 16893673 ↗
• 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 16112453 ↗
• 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 16111021 ↗
• 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 RA

  Patient problems: Tachycardia

  MAUDE report 16110901 ↗
• InjuryDec 21, 2021Adverse 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, CORONARY ARTERY BYPASS GRAFTING AND RECONSTRUCTION OF ASCENDING AORTA WITH 28NN INTERPOSITION GRAFT THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP AND CARDIOBLATE MAPS PEN POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIOTOMY WAS INCISED, AMPUTATED AND SUTURED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED, AS CORONARY ARTERY BYPASS AFTER MAZE UNABLE TO ACCESS PULMONARY VEIN. APPROXIMATELY 7 DAYS POST PROCEDURE THE PATIENT EXPERIENCED VENTRICULAR ESCAPE RHYTHM UNDERLYING PACER AFTER GOING INTO ATRIAL FIBRILLATION. THE PATIENT STATUS WAS RECOVERED/RESOLVED TWO DAYS LATER. THE ADVERSE EVENT WAS DEEMED BY THE SITE POSSIBLY RELATED TO CARDIOBLATE BP2 CLAMP, CRYOFLEX PROBE, CONCOMITANT PROCEDURE AND STUDY PROCEDURE.

  Patient problems: Arrhythmia; Atrial Fibrillation

  MAUDE report 13052284 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AN AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING THROUGH STERNOTOMY.  DURING THE SAME PROCEDURE, A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, A CARDIOBLATE LP CLAMP AND CARDIOBLATE MAPS ABLATION PEN POWERED BY A CARDIOBLATE GENERATOR, WERE USED. THE LEFT ARTERIOTOMY WAS INCISED, AMPUTATED AND SUTURED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT PERFORMED (UNABLE TO ACCESS PV). APPROXIMATELY 6 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION RECURRENCE. THE PATIENT WAS STARTED ON AN AMIODARONE DRIP THE FOLLOWING DAY. THE PATIENT CONVERTED TO NORMAL SINUS RHYTHM (NSR) TWO DAYS LATER. THE PATIENT WAS DISCHARGED ON AMIODARONE 200MG PO, 1 TAB QD FOR 3 WEEKS, THEN TO DISCONTINUE. THE PATIENT STATUS WAS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CARDIOBLATE CLAMP AND THE CRYOFLEX PROBE, STUDY PROCEDURE AND CONCOMITANT PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE PROCEDURE.

  Patient problems: Atrial Fibrillation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052013 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD THE FOLLOWING CONCOMITANT SURGICAL PROCEDURES MITRAL VALVE REPAIR, TRICUSPID VALVE REPAIR AND CORONARY ARTERY BYPASS GRAFTING (FOUR ANASTOMOSES) THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ((B)(6) 2019) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE AND A CARDIOBLATE BP2 CLAMP AND A CARDIOBLATE MAPS POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2019 THE PATIENT EXPERIENCED RIGHT BUNDLE BRANCH BLOCK. THE PATIENT STATUS IS NOT RECOVERED/NOT RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE AND CRYOFLEX PROBE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CARDIOBLATE BP2 CLAMP.

  Patient problems: Complete Heart Block; Heart Block

  MAUDE report 9265644 ↗