Cardioblate® CryoFlex® 60SF3 (UDI 00643169183865)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169183865), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 8173453 ↗

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-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
• 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