AtriClip® FLEX-Mini™ LAA Exclusion System ACHM40Recalls & reported problems
Atricure, Inc. · LAA Exclusion System, ACHM40 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143911781), received between Jan 29, 2025 and Jan 29, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Cardiac Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2025Use of Device Problem; Use of Device Problem
A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) USING AN ACHM40 CLIP. FOLLOWING DEPLOYMENT OF CLIP DEVICE, THE HEART WAS ROTATED, REVEALING THAT THE ACHM40 CLIP WAS NOT POSITIONED AT THE BASE OF THE APPENDAGE. THE SURGEON DECIDED TO REMOVE THE CLIP, BUT INADVERTENTLY TORE THE DISTAL TIP OF THE LEFT ATRIAL APPENDAGE DURING THE CLIP DEVICE REMOVAL. FOLLOWING THIS, THE SURGEON SUCCESSFULLY APPLIED AN ACHV CLIP AND BLEEDING WAS CONTROLLED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Cardiac Perforation
MAUDE report 21267854 ↗
Other Left Atrial Appendage Clip, Implantable devices
- Penditure™ LAAC45Medtronic, Inc. · Left atrial appendage clip, implantable7 reports
- Penditure™ LAAC50Medtronic, Inc. · Left atrial appendage clip, implantable1 death7 reports
- Penditure™ LAAC40Medtronic, Inc. · Left atrial appendage clip, implantable6 reports
- Penditure™ LAAC35Medtronic, Inc. · Left atrial appendage clip, implantable2 reports
- AtriClip PROV® LAA Exclusion System PROV50Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 death1 report
- AtriClip® FLEX-Mini™ LAA Exclusion System ACHM50Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 report
- AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion System PRO235Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 report
- AtriClip® FlexV® LAA Exclusion System ACHV45Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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