CARDIOBLATE® 60841Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885074359618), received between Dec 18, 2018 and Mar 31, 2023 — classified as 2 deaths, 7 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 9 most recent of 9 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 16654089 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF LEFT ATRIAL MYXOMA EXCISION, INSERTION VA ECMO THROUGH MINIMALLY INVASIVE / THORACOTOMY. DURING THE SAME PROCEDURE ON ((B)(6) 2021) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS CLOSED. LEFT PULMONARY VEIN (LPV) WAS NOT PERFORMED AS THE PROCEDURE WAS A RIGHT MINI-THORACOTOMY APPROACH AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON ((B)(6) 2021) THE PATIENT EXPERIENCED A PULMONARY HEMORRHAGE. ON COMING OFF BYPASS, THE CUSTOMER NOTED FRANK BLEEDING FROM ETT ALONG WITH HYPOTENSION. THEY WERE UNABLE TO VENTILATE OFF BYPASS. PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST OCCURRED DURING A PERIOD OF HYPOTENSION AND HYPOXEMIA. THE PATIENT WAS PLACED ON ECMO. 18 UNITS OF PACKED RED BLOOD CELLS (PRBCS) WERE GIVEN IN THE OPERATING ROOM. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2021 FOR FURTHER CLOT EVACUATION. AN ADDITIONAL 8 UNITS OF PACKED RED BLOOD CELLS (PRBCS) WERE GIVEN. THE HEMATOCRIT WAS NORMAL BY DISCHARGE. THE PATIENT¿S CONDITION WAS CLASSED AS RECOVERED/RESOLVED (B)(6) 2021 THE ADVERSE EVENT WAS DEEMED BY T

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 12195049 ↗
• InjuryFeb 28, 2020Adverse 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, MITRAL VALVE REPLACEMENT THROUGH STERNOTOMY. 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. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND SUTURED CLOSED. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WAS NOT ACHIEVED DUE TO PATIENT BEING IN ATRIAL FIBRILLATION. ON THE DAY AFTER THE PROCEDURE (B)(6) 2019) THE PATIENT NEEDED REINTUBATION WHICH WAS TREATED WITH CONCOMITANT/ADDITIONAL MEDICATION AND PROLONGED HOSPITALIZATION. THE PATIENT RECOVERED (B)(6) 2019). THE ADVERSE EVENT WAS DEEMED BY THE SITE AS CAUSALLY RELATED TO THE CONCOMITANT PROCEDURE AND UNLIKELY RELATED TO THE STUDY DEVICES AND THE STUDY PROCEDURE. THIS IS MUCH MORE LIKELY TO BE RELATED TO THE DOUBLE VALVE PROCEDURE.

  Patient problems: Extubate; Respiratory Failure

  MAUDE report 9769183 ↗
• InjuryNov 25, 2019Adverse 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 GRAFTING (CABG) THROUGH STERNOTOMY. 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. 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, CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE.

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

  MAUDE report 9368312 ↗
• DeathNov 18, 2019Adverse 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 GRAFTING THROUGH STERNOTOMY. 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. THE LEFT ATRIAL APPENDAGE WAS AMPUTATED, EXCISED AND CLOSED. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WERE NO PERFORMED FOR PATIENT SAFETY. ON THE SAME DAY AS THE PROCEDURE ((B)(6) 2019) THE PATIENT EXPERIENCED POST OPERATIVE RESPIRATORY FAILURE. THE PATIENT EXPIRED ON (B)(6) 2019. THE CAUSE OF DEATH WAS DETERMINED TO BE NON-CARDIAC DEATH. THE ADVERSE EVENT AND DEATH WERE DEEMED BY THE SITE AS RELATED TO THE CONCOMITANT PROCEDURE BUT NOT RELATED TO THE CRYOFLEX PROBE, C RYOCONSOLE, CARDIOBLATE LP CLAMP AND CARDIOBLATE GENERATOR. CEC ADJUDICATED AS POSSIBLY RELATED TO STUDY PROCEDURE, CONCOMITANT PROCEDURE AND ALL DEVICES USED.

  Patient problems: Death; Respiratory Failure

  MAUDE report 9334319 ↗
• 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: Complete Heart Block

  MAUDE report 9267251 ↗
• 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 8974488 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE ((B)(6) 2018) A CARDIOBLATE LP CLAMP AND CRYOFLEX PROBE WERE USED THROUGH A STERNOTOMY TO TREAT THE PATIENTS AF. LEFT PULMONARY VEIN CONDUCTION BLOCK WAS NOT PERFORMED DUE TO A POSSIBLE CLOT IN THE LEFT ATRIAL APPENDAGE. RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WAS NOT PERFORMED. THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AMPUTATED/EXCISED AND OVERSEWN. ON (B)(6) 2018 THE PATIENT EXPERIENCED A GASTROINTESTINAL BLEED. A COLONOSCOPY WAS CARRIED OUT AND IT SHOWED MULTIPLE ULCERS IN ASCENDING AND DESCENDING COLON. DURING THE COLONOSCOPY A HEMOSTATIC CLIP WAS PLACED AT ONE BLEEDING SITE. THE PATIENT¿S HAEMOGLOBIN WAS 7.5. THE PATIENT WAS HOSPITALIZED FROM THE (B)(6) UNTIL THE (B)(6). THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND CONCOMITANT OR ADDITIONAL MEDICATION BECAUSE OF THIS ADVERSE EVENT. THE ADVERSE EVENT WAS DEEMED AS UNLIKELY RELATED TO THE STUDY PROCEDURE AND UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE. THE CUSTOMER STATED THAT THE STRESS OF SURGERY MAY HAVE CONTRIBUTED. THE ADVERSE EVENT WAS DEEMED AS NOT RELATED TO THE STUDY DEVICES.

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

  MAUDE report 8332025 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE ((B)(6) 2018) A "CYROFLEX" PROBE AND CARDIOBLATE BIPOLAR CLAMP WERE USED THROUGH STERNOTOMY TO TREAT THE PATIENTS AF. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK ACHIEVED. THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPLACEMENT AND AMPUTATED/EXCISED AND OVERSEWN. APPROXIMATELY 7 DAYS POST PROCEDURE THE PATIENT EXPERIENCED COMPLETE HEART BLOCK REQUIRING A PERMANENT PACEMAKER. THE PATIENT RECEIVED A PACEMAKER. PATIENT WAS DISCHARGED 13 DAYS POST PROCEDURE ((B)(6) 2018) WITH SINUS RHYTHM. THE ADVERSE EVENT WAS DEEMED AS BEEN NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE STUDY AND CONCOMITANT PROCEDURE. NEED FOR A "PACEMARKER" IMPLANTATION IS A KNOWN COMPLICATION TO SURGICAL ABLATION AND MITRAL VALVE REPLACEMENT. THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPLACEMENT AND AMPUTATED/EXCISED AND OVERSEWN.

  Patient problems: Complete Heart Block

  MAUDE report 8173451 ↗