Cannula with Guide CSK-6131Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840143901607), received between Oct 28, 2024 and May 14, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CONVERGENT PROCEDURE VIA SUBXIPHOID APPROACH WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION. THE EPI-SENSE CANNULA (CSK-6131) WAS PLACED AND AS THE SURGEON REPOSITIONED THE CANNULA TO IDENTIFY LANDMARKS, AN INJURY TO IVC OCCURRED. THE PROCEDURAL APPROACH WAS CONVERTED TO MEDIAN STERNOTOMY, AND THE INJURY WAS SUCCESSFULLY REPAIRED. THE PROCEDURE WAS THEN COMPLETED, UTILIZING AN ENCOMPASS CLAMP AND AN ACH245 CLIP DEVICE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 22022941 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CONVERGENT PROCEDURE VIA SUBXIPHOID APPROACH WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION. AFTER INSERTING EPI-SENSE CANNULA (CSK-6131), BLEEDING WAS OBSERVED, PROMPTING ITS REMOVAL, AFTER WHICH PERFORATION OF THE RIGHT VENTRICLE WAS NOTED. THE PROCEDURAL APPROACH WAS CONVERTED TO MEDIAN STERNOTOMY, AND THE INJURY WAS REPAIRED USING SUTURES. THE PATIENT WAS STABILIZED, AND AN ATRICLIP DEVICE WAS PLACED ON THE LEFT ATRIAL APPENDAGE. NO ABLATION WAS PERFORMED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 22022904 ↗
• InjuryOct 28, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PATIENT UNDERWENT A CONVERGENT PROCEDURE WITH LEFT ATRIAL APPENDAGE MANAGEMENT. WHEN ADVANCING THE CSK-6131 CANNULA INTO THE SUB-XIPHOID SPACE, AN INJURY WAS MADE TO THE INFERIOR VENA CAVA. THE PROCEDURE WAS CONVERTED TO A STERNOTOMY AND THE INJURY WAS REPAIRED WITH BOVINE PATCH. THE CONCOMITANT PROCEDURE WAS PERFORMED BUT NOT COMPLETED AS ONLY THE LEFT SIDE LESIONS WERE COMPLETED. THE PATIENT WAS STABLE AND TRANSFERRED TO ICU POST-OPERATIVELY. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 20548339 ↗