Cardioblate® CryoFlex® 60SF2 (UDI 00763000114619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000114619), received between Jun 13, 2019 and Dec 27, 2023 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier.

4 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.

Recalls naming this device

1. Oct 12, 2020Terminated

   There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

   Z-0493-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 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

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE EVENT WAS DELETED FROM THE DATABASE WITH FOLLOWING COMMENT: "THIS IS A PRE-EXISTING CONDITION AND NOT WORSENING."

  Patient problems: Arrhythmia

  MAUDE report 18396626 ↗
• 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 THE (B)(6) 2021. DURING THE PROCEDURE ON THE (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 THE (B)(6) 2023 THE PATIENT EXPERIENCED  NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE PATIENT HAD THREE EPISODES ON THE 12-MONTH HO LTER MONITOR REPORT. THE PATIENT STATUS WAS RECOVERED/RESOLVED ON THE (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 CRYO

  Patient problems: Tachycardia

  MAUDE report 16893683 ↗
• MalfunctionApr 12, 2023Crack; Material Deformation; Crack; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CRYOFLEX PROBE, IT WAS REPORTED THAT THE TIP BROKE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725417 ↗
• 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, ASCENDING AORTA REPLACEMENT, MAZE, LEFT ATRIAL APPENDAGE (LAA) LIGATION 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 STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. 21 DAYS LATER, ON (B)(6) 2022 THE PATIENT EXPERIENCED ATRIAL FLUTTER. THE PATIENT CAME IN DURING THEIR 1 MONTH VISIT AND WAS FOUND TO BE IN ATRIAL FLUTTER. THE ADVERSE EVENT WAS TREATED WITH MEDICATION, PERCUTANEOUS INTERVENTION AND EXTERNAL CARDIOVERSION. THREE DAYS LATER, THE PATIENT RECOVERED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE AND THE CRYOCONSOLE BUT NOT RELATED TO THE CRYOFLEX PROBE, CARDIOBLATE LP CLAMP OR THE FT-10 GENERATOR. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, STUDY PROCEDURE AND THE CRYOFLEX PROBE, CARDIOBLATE LP CLAMP BUT NOT RELATED TO THE CRYOCONSOLE OR THE FT-10 GENERATOR.

  Patient problems: Atrial Flutter

  MAUDE report 16112603 ↗
• 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 M NITOR 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 RA

  Patient problems: Tachycardia

  MAUDE report 16110906 ↗
• InjuryDec 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 AORTIC VALVE REPLACEMENT, ASCENDING AORTA REPLACEMENT, MAZE AND LEFT ATRIAL APPENDAGE (LAA) LIGATION PROCEDURE THROUGH STERNOTOMY. DURING THE SAME PROCEDURE ON (B)(6) 2022 A CRYOFLEX PROBE POWERED BY A CRYO-CONSOLE, AND A CARDIOBLATE LP CLAMP POWERED BY AN FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. PATIENT HAD BEEN IN JUNCTIONAL RHYTHM DURING THE PROCEDURE AND SWITCHED TO VENTRICULAR PACED RHYTHM, THE NEXT DAY ON (B)(6) 2022. PATIENT SWITCHED BACK TO JUNCTIONAL RHYTHM AND STAYED THAT WAY FOR 5 DAYS UNTIL (B)(6) 2022.  EVENT WAS TREATED WITH MEDICATION AND PERCUTANEOUS INTERVENTION. THE PATIENT RECOVERED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS NOT RELATED TO THE CRYOFLEX PROBE, CARDIOBLATE LP CLAMP OR FT-10 GENERATOR AND RELATED TO THE STUDY PROCEDURE, CONCOMITANT PROCEDURE AND CRYO-CONSOLE INSTRUMENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO CONCOMITANT PROCEDURE, STUDY PROCEDURE, CRYOFLEX PROBE, AND THE CARDIOBLATE LP CLAMP.

  Patient problems: Arrhythmia

  MAUDE report 16032949 ↗
• InjuryNov 29, 2022Adverse 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 THROUGH STERNOTOMY. DURING THE SAME PROCEDURE 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 STAPLED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE ACHIEVED. 6 DAYS LATER, THE PATIENT EXPERIENCED A TACHYBRADYCARDIA. A SINUS RHYTHM WITH FIRST-DEGREE AV BLOCK WAS NOTED FOR A PERIOD OF TIME, THE PATIENT CONTINUED TO HAVE INTERMITTENT PERIODS OF JUNCTIONAL RHYTHM. THE EP WAS CONSULTED AFTER TWO DAY, THE PATIENT UNDERWENT A PERMANENT PACEMAKER (PPM) USING A MEDTRONIC DUAL CHAMBER PACEMAKER WITH LEFT BUNDLE BRANCH AREA PACING. THERE WAS NO INTRA PROCEDURAL COMPLICATIONS. THEY DID NOT OBSERVED SINUS NODE FUNCTION SINCE SURGERY, NOTED ON POST-OP DAY 5. THE SINUS NODE WAS POSSIBLY INJURED DURING THE SURGERY. POST-OP, THE PATIENT HAD BEEN IN JUNCTIONAL RHYTHM RATE OF 40S TO 50S WITH OCCASIONAL RARE SINUS BEAT. THE PATIENT WAS RECOVERED/RESOLVED 1 DAY POST PPM. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLE RELATED TO THE STUDY DEVICES, STUDY PROCEDURE AND CONCOMITANT PROCEDURE.

  Patient problems: Bradycardia

  MAUDE report 15876224 ↗
• InjuryOct 25, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CRYOFLEX PROBE, IT WAS REPORTED THAT THE PLASTIC SLEEVE BEGAN TO BREAK AND CRUMBLE. THE CUSTOMER STATED THAT THE PROBE CONTINUED TO WORK AND FREEZE TISSUE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665377 ↗
• InjuryDec 21, 2021Adverse 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 AND RECONSTRUCTION OF ASCENDING AORTA WITH 28NN INTERPOSITION GRAFT THROUGH STERNOTOMY. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND A CARDIOBLATE BP2 CLAMP AND CARDIOBLATE MAPS PEN POWERED BY A CARDIOBLATE GENERATOR WERE USED. THE LEFT ATRIOTOMY WAS INCISED, AMPUTATED AND SUTURED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED, AS CORONARY ARTERY BYPASS AFTER MAZE UNABLE TO ACCESS PULMONARY VEIN. APPROXIMATELY 7 DAYS POST PROCEDURE THE PATIENT EXPERIENCED VENTRICULAR ESCAPE RHYTHM UNDERLYING PACER AFTER GOING INTO ATRIAL FIBRILLATION. THE PATIENT STATUS WAS RECOVERED/RESOLVED TWO DAYS LATER. THE ADVERSE EVENT WAS DEEMED BY THE SITE POSSIBLY RELATED TO CARDIOBLATE BP2 CLAMP, CRYOFLEX PROBE, CONCOMITANT PROCEDURE AND STUDY PROCEDURE.

  Patient problems: Arrhythmia; Atrial Fibrillation

  MAUDE report 13052345 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF AN AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING THROUGH STERNOTOMY. DURING THE SAME PROCEDURE, A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, A CARDIOBLATE LP CLAMP AND CARDIOBLATE MAPS ABLATION PEN POWERED BY A CARDIOBLATE GENERATOR, WERE USED. THE LEFT ARTERIOTOMY WAS INCISED, AMPUTATED AND SUTURED. LEFT PULMONARY VEIN (LPV) AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WERE NOT PERFORMED (UNABLE TO ACCESS PV). APPROXIMATELY 6 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION RECURRENCE. THE PATIENT WAS STARTED ON AN AMIODARONE DRIP THE FOLLOWING DAY. THE PATIENT CONVERTED TO NORMAL SINUS RHYTHM (NSR) TWO DAYS LATER. THE PATIENT WAS DISCHARGED ON AMIODARONE 200MG PO, 1 TAB QD FOR 3 WEEKS, THEN TO DISCONTINUE. THE PATIENT STATUS WAS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CARDIOBLATE CLAMP AND THE CRYOFLEX PROBE, STUDY PROCEDURE AND CONCOMITANT PROCEDURE. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE PROCEDURE.

  Patient problems: Atrial Fibrillation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052056 ↗
• InjuryOct 23, 2020Adverse 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. DURING THE SAME PROCEDURE A CRYOFLEX PROBE POWERED BY A CRYOCONSOLE, AND CARDIOBLATE LP CLAMPS POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND OVER-SEWN. LEFT PULMONARY VEIN (PV) AND RIGHT PULMONARY VEIN (PV) CONDUCTION BLOCK WERE SUCCESSFULLY ACHIEVED. THREE DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED HEMATOLOGICAL ACUTE BLOOD LOSS ANEMIA. THE PATIENT'S HEMOGLOBIN HAD DRIFTED DOWN TO 6.9G/DL AND IT WAS TREATED WITH TWO UNITS OF RED BLOOD CELLS THE PATIENT RECOVERED ON THE FOLLOWING DAY. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE BUT NOT RELATED TO THE STUDY DEVICES OR THE STUDY PROCEDURE. THE SITE STATED THAT THIS WAS A COMMON OCCURRENCE FOLLOWING CARDIAC SURGERY. THE CLINICAL EVENTS COMMITTEE (CEC) DEEMED A RELATIONSHIP BETWEEN THE CONCOMITANT PROCEDURE AND STUDY PROCEDURE TO THE ADVERSE EVENT AND A POSSIBLE RELATIONSHIP TO THE STUDY DEVICES WITH THE EXCEPTION OF THE CRYOCONSOLE. THE CEC DEEMED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE CRYOCONSOLE.

  Patient problems: Anemia; Blood Loss

  MAUDE report 10725383 ↗
• MalfunctionJul 26, 2019Gas/Air Leak; Gas/Air Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE CRYOCATH PROBE ((B)(4)), ON THE SECOND FREEZE IT STARTED TO PROFUSELY LEAK GAS. THE DEVICE WAS REPLACED. NO PATIENT INJURY OCCURRED BUT THE SURGERY WAS DELAYED FOR SEVERAL MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829937 ↗
• InjuryJun 13, 2019Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE 60SF2 CRYOCATH PROBE, AFTER PERFORMING 2 ONE-MINUTE FREEZES AND 1 TWO-MINUTE FREEZE, THE PROBE BROKE AND FELL INTO THE PATIENT. THE CUSTOMER HAD USED WARM SALINE TO DEFROST THE PROBE. THE PROBE WAS RETRIEVED BY FORCEPS WITH NO TISSUE DAMAGE. THERE WAS NO DIFFICULTY RETRIEVING THE BROKEN PIECE OF THE PROBE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8695050 ↗

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-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
• 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