Cardioblate® CryoFlex® 65CS1 (UDI 00643169183834)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169183834), received between Nov 1, 2019 and Dec 27, 2023 — classified as 1 death, 4 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 16, 2026.

Recalls naming this device

1. Sep 27, 2021Open, 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 6 most recent of 6 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 18396634 ↗
• 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 16112589 ↗
• 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 16111059 ↗
• 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 9408980 ↗
• DeathNov 21, 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 NOT 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 9353338 ↗
• 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 9266527 ↗