AtriClip® LAA Exclusion System PRO240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10840143900181), received between May 13, 2022 and Sep 14, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device 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. 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.

• InjurySep 14, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023 A 73-YEAR-OLD MALE PATIENT UNDERWENT A HYBRID (CONVERGENT APPROACH) ABLATION PROCEDURE WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION. THE ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY. WHILE MANIPULATING THE LEFT ATRIAL APPENDAGE WITH AN ENDOSCOPIC KITTNER AND POSITIONING THE PRO240 ATRICLIP DEVICE, BLEEDING WAS OBSERVED. THE PROCEDURE WAS CONVERTED TO MEDIAN STERNOTOMY APPROACH AND THE INJURY, LOCATED AT THE BASE OF THE PULMONARY ARTERY AND RIGHT VENTRICULAR OUTFLOW TRACT, WAS REPAIRED SUCCESSFULLY. POST-OPERATIVELY, THE PATIENT DEVELOPED SEPSIS AND EXPIRED. IT IS UNKNOWN IF AN AUTOPSY WILL BE CONDUCTED TO DETERMINE CAUSE OF DEATH. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cardiac Perforation

  MAUDE report 17749825 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 A PATIENT UNDERWENT A ROBOTIC CRYO MAZE WITH CONCOMITANT LEFT ATRIAL APPENDAGE MANAGEMENT. PRIOR TO CLIP PLACEMENT, THE PHYSICIAN NOTICED A THROMBUS IN THE LAA, BUT PROCEEDED WITH THE PROCEDURE. THE CLIP WAS DEPLOYED AND DURING DEPLOYMENT THE THROMBUS MIGRATED INTO THE LEFT ATRIUM AND THEN OUT OF THE ATRIUM INTO THE BODY. POST-PROCEDURE, THE CLOT EMBOLIZED TO LEFT KIDNEY AND WAS REMOVED IN A FOLLOW-UP PROCEDURE. THE PATIENT IS DOING WELL AND THERE WERE NO LONG-TERM COMPLICATIONS. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14394557 ↗