EPi-Sense Guided Coagulation System with VisiTrax CDK-1413Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10840143904554), received between Dec 15, 2022 and Jul 26, 2024 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K120857, K142084, P200002); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A HYBRID CONVERGENT EPICARDIAL AND ENDOCARDIAL ABLATION PROCEDURE VIA A SUB-XYPHOID APPROACH USING A CDK-1413 DEVICE. POST-PROCEDURE ELECTROCARDIOGRAM (ECG) INDICATED THE PATIENT WAS IN SINUS RHYTHM, AND THEY WERE DISCHARGED ON POST-OPERATIVE DAY 3. HOWEVER, ON POST-OPERATIVE DAY 4, A TTE REVEALED A MODERATE TO LARGE PERICARDIAL EFFUSION. THE PATIENT WAS READMITTED ON POST-OPERATIVE DAY 8 AND TREATED WITH STEROIDS. THEY WERE DISCHARGED HOME ON POST-OPERATIVE DAY 13 BUT RETURNED ON POST-OPERATIVE DAY 19, COMPLAINING OF SHORTNESS OF BREATH, AND WERE SUBSEQUENTLY ADMITTED FOR A PERICARDIAL WINDOW. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Pericardial Effusion

  MAUDE report 19838800 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 A 79-YEAR-OLD FEMALE PATIENT UNDERWENT AN OFF-PUMP CONVERGENT PROCEDURE WITH LEFT ATRIAL APPENDAGE EXCLUSION. THAT EVENING, THE PATIENT HAD SOME APHASIA AND DIFFICULTY FOLLOWING COMMANDS. IMAGING CONFIRMED AN EMBOLIC STROKE. PATIENT IS IMPROVING AND HAS BEEN MOVED TO A SPECIALIZED CARE FACILITY. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE EVENT IS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Ischemia Stroke

  MAUDE report 15988202 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120857, K142084, P200002. One submission often covers many models, so check the product and lot details in each record.

• Z-1887-2019 · May 29, 2019 · Terminated
  EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, dis