Cardioblate™ 49321Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169997998), received between Nov 4, 2021 and Nov 6, 2023 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 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 AND CABG THROUGH STERNOTOMY. ON THE DAY OF THE PROCEDURE A CYROFLEX PROBE AND A CARDIOBLATE BP2 CLAMP WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY CLOSED. LEFT PULMONARY VEIN (LPV) BLOCK WAS NOT PERFORMED. RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS NOT PERFORMED. AS PATIENT WAS IN AFIB ON THE SAME DAY, THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM. THE PATIENT WAS TREATED WITH AN IMPLANTABLE JUNCTIONAL RHYTHM DEVICE- PACE MAKER. THIS WAS IMPLANTED DUE TO A COMPLETE HEART BLOCK. THE PATIENT STATUS WAS RECOVERED/RESOLVED. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS RELATED TO THE CONCOMITANT PROCEDURE AND THE STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE CONCOMITANT PROCEDURE, THE STUDY PROCEDURE AND THE STUDY DEVICES. THE RATIONALE FOR RELATING TO THE CONCOMITANT PROCEDURE IS AVR RELATED JUNCTIONAL RHYTHM. THE RATIONALE FOR RELATING TO THE STUDY DEVICE IS ABLATION RELATED TO EDEMA.

  Patient problems: Arrhythmia

  MAUDE report 18072233 ↗
• InjuryNov 4, 2021Adverse 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 A STERNOTOMY. DURING THE SAME PROCEDURE ON ((B)(6) 2021) A CRYOFLEX PROBE AND A CARDIOBLATE BP2 FT-10 CLAMP POWERED BY A FT-10 GENERATOR WERE USED. THE LEFT ATRIAL APPENDAGE WAS SUCCESSFULLY AMPUTATED/EXCISED AND OVER-SEWN. LEFT PULMONARY VEIN (LPV) CONDUCTION BLOCK WAS NOT PERFORMED DUE TO PATIENT ANATOMY AND RIGHT PULMONARY VEIN (RPV) CONDUCTION BLOCK WAS SUCCESSFULLY ACHIEVED. ON THE SAME DAY AS THE PROCEDURE ((B)(6) 2021), THE PATIENT EXPERIENCED JUNCTIONAL RHYTHM, WHICH WAS TREATED BY STOPPING AMIODARONE. THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE CRYOFLEX PROBE AND CARDIOBLATE BP2 FT-10 CLAMP, STUDY DEVICES, PROBABLY RELATED TO THE STUDY PROCEDURE AND THE CONCOMITANT PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 12750539 ↗