AtriClip® FLEX-Mini™ LAA Exclusion System ACHM50Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143911804), received between May 14, 2026 and May 14, 2026 — classified as 1 injury.

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.

• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) AND AORTIC VALVE REPLACEMENT/REPAIR (AVR) VIA MEDIAN STERNOTOMY WITH CONCOMITANT TAMPA 2 SURGICAL ABLATION LESION SET AND LEFT ATRIAL APPENDAGE EXCLUSION (LAAE). AN INCISION WAS MADE IN THE LEFT ATRIAL APPENDAGE (LAA) FOR ACCESS TO PERFORM THE TAMPA 2 LESION SET, WHICH WAS COMPLETED AS PLANNED. AN ACHM50 ATRICLIP DEVICE WAS DEPLOYED AFTER THE CONCOMITANT SURGICAL ABLATION PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS TRANSFERRED TO THE OPEN-HEART RECOVERY UNIT BUT WAS SUBSEQUENTLY RETURNED TO THE OPERATING ROOM DUE TO BLEEDING. UPON EVALUATION, THE SURGEON IDENTIFIED A SMALL LEAK AT THE LAA OSTIUM, NEAR THE SITE OF THE ACCESS INCISION. THE LAA WAS OVERSEWN, AND THE PATIENT RECOVERED WITHOUT FURTHER REPORTED COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25172950 ↗