AtriClip PROV® LAA Exclusion System PROV50Recalls & reported problems
Atricure, Inc. · LAA Exclusion System, PROV50 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143913556), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 death.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A VIDEO-ASSISTED THORACOSCOPY (VATS) FOR STANDALONE LEFT ATRIAL APPENDAGE EXCLUSION USING A PROV50 ATRICLIP DEVICE. DUE TO LUNGS BEING ADHERED TO PERICARDIUM AND CHEST WALL THE PROCEDURAL APPROACH WAS CONVERTED TO A THORACOTOMY. THE PROV50 DEVICE WAS ADVANCED THROUGH 12MM PORT AT THE SIXTH INTERCOSTAL SPACE. THE PROV50 WAS REMOVED AND REINTRODUCED VIA THE THORACOTOMY AT THE FOURTH INTERCOSTAL SPACE. WHILE POSITIONING DEVICE AROUND THE LEFT ATRIAL APPENDAGE (LAA) A TEAR AT THE BASE OF THE LAA AND DOME OF THE ATRIUM OCCURRED. AN ATTEMPT TO DEPLOY THE CLIP WAS UNSUCCESSFUL. AFTER APPROXIMATELY ONE HOUR, THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS, AND THE TEAR WAS SUTURED VIA THORACOTOMY. DESPITE THESE MEASURES, THE PATIENT EXPIRED IN THE OPERATING ROOM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23852097 ↗
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® 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® FLEX-Mini™ LAA Exclusion System ACHM40Atricure, 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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