Cardioblate® CryoFlex® 65CS1 (UDI 00763000014988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000014988), received between Oct 12, 2022 and Oct 23, 2024 — classified as 1 death, 9 injuries, 1 malfunction.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 27, 2021Class IIOpen, Classified

   There is potential for intermittent electrical connectivity between the console and probe.

   Z-0273-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Adverse 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 THROUGH MINIMALLY INVASIVE / THORACOTOMY ON THE (B)(6) 2024. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BYAN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON (B)(6) 2024, THE PATIENT EXPERIENCED PROLONGED QTC. PROLONGED QTC INTERVAL NOTED ON ECG DURING INDEX PROCEDURE HOSPITALIZATION. THE PATIENT STATUS IS DOWN AS RECOVERING/ RESOLVING THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE OR THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 20514027 ↗
• InjuryOct 23, 2024Adverse 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 THROUGH MINIMALLY INVASIVE THORACOTOMY. DURING THE SAME PROCEDURE ON THE ((B)(6) 2024) 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. THE LEFT PULMONARY VEIN (LPV) WAS NOT PERFORMED DUE TO THE THORACOTOMY SURGICAL APPROACH. THE RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ON THE ((B)(6) 2024) THE PATIENT EXPERIENCED SINUS NODE DYSFUNCTION. SINUS NODE DYSFUNCTION (BRADYCARDIA) WITH AV BLOCK VS BLOCKED PREMATURE ATRIAL CONTRACTIONS (PACS) WAS NOTED ON TELEMETRY WHILE ADMITTED FROM THE INDEX PROCEDURE. ANTIARRHYTHMIC MEDICATIONS BEING HELD DUE TO CONTRAINDICATION WITH RHYTHM. A PACEMAKER WAS INSERTED. THE PATIENTS OUTCOME STATUS WAS RECOVERING/RESOLVING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CARDIOBLATE LP CLAMP, THE CRYOFLEX PROBE, THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE CARDIOBLATE LP CLAMP, THE CRYOFLEX PROBE AND THE CARDIOBLATE CRYOFLEX CONSOLE AND REL

  Patient problems: Arrhythmia

  MAUDE report 20512744 ↗
• InjuryFeb 20, 2024Adverse 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 AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON THE (B)(6) 2023 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 OVERSEWN. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED. THE SURGEON ATTEMPTED TO PERFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION.  ON THE (B)(6) 2023 THE PATIENT EXPERIENCED ATRIAL FLUTTER ON ONE MONTH ELECTROCARDIOGRAM (ECG) STUDY. THE PATIENT STATUS WAS RECOVERING/RESOLVING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE STUDY DEVICES, STUDY PROCEDURE AND CONCOMITANT PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 18739263 ↗
• InjuryNov 14, 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 AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE PROCEDURE 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 OVERSEWN. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT SUCCESSFULLY ACHIEVED. THE SURGEON ATTEMPTED TO PREFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION. THE PATIENT EXPERIENCED EDEMA AND A 17 POUND WEIGHT INCREASE FROM BASELINE, ADDITIONAL FUROSEMIDE GIVEN. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE STUDY PROCEDURE, THE CONCOMITANT PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR RELATING THE CONCOMITANT PROCEDURE WAS LIKELY DUE TO THE LONGER OPERATION BECAUSE OF TWO HALVES. THE RATIONALE FOR RELATING TO THE STUDY DEVICES WAS DUE TO A LONGER RUN CARDIOPULMONARY BYPASS DUE TO THE TWO HALVES SURGERY. THE PATIENT OUTCOME STATUS IS RECOVERING/RESOLVING.

  Patient problems: Swelling/ Edema

  MAUDE report 18131080 ↗
• MalfunctionNov 14, 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 AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE PROCEDURE 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 OVERSEWN. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT ACHIEVED. THE SURGEON ATTEMPTED TO PREFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION. THE PATIENT EXPERIENCED NEW COMPLETE HEART BLOCK AFTER INDEX PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE STUDY PROCEDURE, THE CONCOMITANT PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR UNLIKELY RELATING TO THE STUDY DEVICE AND CONCOMITANT PROCEDURE WAS BECAUSE THE LESIONS WERE NOT IN THE PROXIMITY OF THE AV NODE. THE OUTCOME STATUS OF THE PATIENT IS RECOVERING/RESOLVING.

  Patient problems: Heart Block

  MAUDE report 18129600 ↗
• InjuryNov 14, 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 AND TRICUSPID VALVE REPAIR THROUGH STERNOTOMY. DURING THE SAME PROCEDURE 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 OVERSEWN. THE LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCKS WERE NOT PERFORMED. THE SURGEON ATTEMPTED TO PREFORM CONDUCTION BLOCK TESTING BUT WAS NOT ABLE TO DO SO AS THE PATIENT WAS STILL IN ATRIAL FIBRILLATION. THE PATIENT EXPERIENCED NEW JUNCTIONAL RHYTHM AFTER INDEX PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS UNLIKELY RELATED TO THE CARDIOBLATE LP CLAMP AND THE STUDY DEVICES AND POSSIBLY RELATED TO THE CRYOFLEX PROBE, THE STUDY PROCEDURE AND THE CONCOMITANT PROCEDURE. THE RATIONALE FOR POSSIBLY RELATING THE ADVERSE EVENT TO THE CONCOMITANT PROCEDURE WAS DUE TO THE MYOCARDIAL EDEMA FROM LESIONS AND DUE TO MYOCARDIAL EDEMA FROM ANNULAR SUTURES. THE RATIONALE FOR UNLIKELY RELATING THE ADVERSE EVENT TO THE STUDY DEVICE WAS DUE TO MYOCARDIAL EDEMA FROM FREEZE LESION. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CRYOFLEX

  Patient problems: Arrhythmia

  MAUDE report 18129383 ↗
• 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, CRYOC

  Patient problems: Tachycardia

  MAUDE report 16893693 ↗
• InjuryApr 24, 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, CORONARY ARTERY BYPASS GRAFTING (CABG), (NUMBER OF ANASTOMOSES: 1) THROUGH STERNOTOMY ON THE (B)(6) 2023. ON THE DAY OF THE PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE (LAA) CLOSURE WAS AMPUTATED/ EXCISED AND OVER-SEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED AS THE PRE-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) COULD NOT RULE OUT THROMBUS IN THE LAA, PATIENT WAS IN ARTERIAL FIBRILLATION AND CARDIOVERSION WAS CONTRAINDICATED DUE TO THIS, IT WAS STATED THAT THEREFORE BLOCK DID NOT NEED TO BE DONE AS SPECIFIED BY CLINICAL REPRESENTATIVE. THE RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON (B)(6) 2023 THE PATIENT EXPERIENCED NEW JUNCTIONAL RHYTHM AFTER THE INDEX PROCEDURE. ANTIARRHYTHMICS WERE STOPPED DUE TO THE JUNCTIONAL RHYTHM. THE PATIENT STATUS IS RECOVERING/RESOLVING THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, UNLIKELY RELATED TO THE STUDY DEVICES AND PROBABLY RELATED TO THE STUDY PROCEDURE. THE SITE PROVIDED THE FOLLOWING RATI

  Patient problems: Arrhythmia

  MAUDE report 16793838 ↗
• 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 16110915 ↗
• InjuryNov 22, 2022Adverse 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 THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND OVERSEWN. LEFT PULMONARY VEIN (LPV) BLOCK WAS ACHIEVED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS ACHIEVED. ON THE SAME DAY THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM AFTER THE INDEX PROCEDURE. THE PATIENT IS RECOVERING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, STUDY DEVICES AND STUDY PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE AND STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES.

  Patient problems: Arrhythmia

  MAUDE report 15844260 ↗
• DeathOct 12, 2022Adverse 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 AND CORONARY ARTERY BYPASS GRAFTING (CABG) WITH 4 ANAST OMOSES THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON (B)(6) 2022 A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUTURED CLOSED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. ON (B)(6) 2022 THE PATIENT EXPERIENCED CARDIAC ARREST AND SUDDEN CARDIAC DEATH. THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND PROPER PROTOCOL WAS FOLLOWED. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED BUT ONLY FOR A SHORT PERIOD OF TIME. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VFIB) ARREST. THE PATIENT REMAINED PULSELESS. THE TIME OF DEATH OF PATIENT WAS THEN CALLED. THE ADVERSE EVENT WAS DEEMED BY THE SITE CAUSALLY RELATED TO CONCOMITANT PROCEDURE AND STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO CONCOMITANT PROCEDURE, STUDY PROCEDURE AND CRYOCONSOLE, CARDIOBLATE LP CLAMP AND FT-10 GENERATOR ST

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15586206 ↗