AtriClip™ LAA Exclusion System ACH235Recalls & reported problems
Atricure, Inc. · AtriClip® FLEX Gilinov-Cosgrove LAA Exclusion System 35 · 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 10840143900099), received between May 3, 2023 and May 3, 2023 — 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Ventricular Fibrillation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT AN ON-PUMP AORTIC ROOT REPLACEMENT WITH CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) VIA MEDIAN STERNOTOMY. AFTER PLACING THE ATRICLIP, THE MEDIAL END OF THE CLIP CAME IN CONTACT WITH THE BUTTON OF THE LEFT MAINSTEM ARTERY WHERE IT WAS REATTACHED TO THE AORTIC GRAFT. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF), AND THE CLIP WAS REMOVED. THE VF SELF-RESOLVED AND THE PATIENT IS RECOVERING. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTION.
Patient problems: Ventricular Fibrillation
MAUDE report 16862164 ↗
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- Endo Clip III 176630Covidien LP · CLIP, IMPLANTABLE1 death1,959 reports
- Epix® Universal Clip Applier CA500Applied Medical Resources Corporation · Clip, Implantable1 recall1 death1,183 reports
- Endo Clip II 176657Covidien LP · CLIP, IMPLANTABLE1,183 reports
- LIGACLIP ER320Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE1,115 reports
- Direct Drive® Clip Applier CA090Applied Medical Resources Corporation · Clip, Implantable1 death806 reports
- LAPRA-TY XC200Ethicon Inc. · CLIP, IMPLANTABLE791 reports
- Endo Clip 176625Covidien LP · CLIP, IMPLANTABLE1 death768 reports
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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