Cardioblate® CryoFlex® 60SF2 (UDI 00643169183889)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169183889), received between Oct 25, 2019 and Jan 6, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K123733); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 16112485 ↗
• 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 16111038 ↗
• 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 9265651 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF MITRAL VALVE REPAIR, TRICUSPID VALUE REPAIR AND CABG THROUGH STERNOTOMY. DURING THE SAME PROCEDURE (B)(6) 2019) A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, A CARDIOBLATE LP CLAMP AND A CARDIOBLATE MAPS POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS OVERSEWN. 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 COMPLETE ATRIOVENTRICULAR BLOCK WHICH WAS TREATED WITH EPICARDIAL AV PACING. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CRYOFLEX DEVICE AND NOT RELATED TO THE CRYOCONSOLE, CARDIOBLATE LP CLAMP, CARDIOBLATE MAPS POWERED BY A CARDIOBLATE GENERATOR AND POSSIBLY RELATED TO THE CONCOMITANT AND STUDY PROCEDURE.

  Patient problems: Complete Heart Block; Heart Block

  MAUDE report 9238388 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123733. One submission often covers many models, so check the product and lot details in each record.

• Z-0273-2022 · Sep 27, 2021 · Open, Classified
  Cardioblate CryoFlex Surgical Ablation Console
• Z-0494-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex
• Z-0495-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex S
• Z-0493-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use wit
• Z-0496-2021 · Oct 12, 2020 · Terminated
  Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex