Cardioblate® 6800001AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994299413), received between Sep 9, 2019 and Mar 31, 2023 — classified as 1 death, 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 (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 STUDY PR

  Patient problems: Anemia

  MAUDE report 16654084 ↗
• 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 16112884 ↗
• 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 16111067 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF CABG THROUGH STERNOTOMY. DURING THE SAME PROCEDURE (B)(6) 2019) A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WERE NOT PERFORMED FOR PATIENT SAFETY. ON THE SAME DAY AS THE PROCEDURE (B)(6) 2019) THE PATIENT EXPERIENCED ACUTE BLOOD LOSS ANEMIA WHICH WAS TREATED WITH BLOOD TRANSFUSIONS. THE PATIENT RECOVERED ON (B)(6) 2019). THE ADVERSE EVENT WAS DEEMED BY THE SITE AS CAUSALLY RELATED TO THE CONCOMITANT PROCEDURE AND POSSIBLY RELATED TO THE STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES. CEC ADJUDICATED AS POSSIBLY RELATED TO ALL STUDY DEVICES USED.

  Patient problems: Anemia; Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9408990 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF CABG THROUGH STERNOTOMY AND AMPUTATED/EXCISED. DURING THE SAME PROCEDURE (B)(6) 2019) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND CLOSED. APPROXIMATELY 21 DAYS POST PROCEDURE (B)(6) 2019) THE PATIENT EXPERIENCED INCOMPLETE LEFT BUNDLE BRANCH BLOCK. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT AND STUDY PROCEDURES BUT NOT RELATED TO THE CRYOFLEX PROBE, CRYOCONSOLE, CARDIOBLATE LP CLAMP AND CARDIOBLATE GENERATOR. THE ADVERSE EVENT WAS DEEMED BY THE CEC ADJUDICATION AS CAUSALLY RELATED TO BOTH THE CONCOMITANT AND STUDY PROCEDURES AND TO THE CRYOFLEX PROBE, CRYOCONSOLE, CARDIOBLATE LP CLAMP AND CARDIOBLATE GENERATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266543 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF CABG THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ((B)(6) 2019) A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ON THE SAME DAY AS THE PROCEDURE ((B)(6) 2019) THE PATIENT EXPERIENCED PERICARDIAL ARTERY BLEEDING WHICH WAS TREATED WITH A BLOOD TRANSFUSION AND SURGICAL PROCEDURE OF CLIPPING THE BLEEDING ARTERY. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS RELATED TO THE CONCOMITANT PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES AND STUDY PROCEDURE. THE CLINICAL EVENTS COMMITTEE (CEC) DEEMED A CAUSAL RELATIONSHIP BETWEEN THE CONCOMITANT PROCEDURE AND STUDY PROCEDURE TO THE ADVERSE EVENT AND POSSIBLY RELATED TO CRYOFLEX PROBE AND CRYO CONSOLE, AND THE CARDIOBLATE CLAMP AND CARDIOBLATE GENERATOR.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8974458 ↗