AtriClip® LAA Exclusion System PRO245 (REF A000967)Recalls & reported problems
Atricure, Inc. · AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45 · 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 10840143907418), received between Apr 29, 2024 and Apr 29, 2024 — 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.
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.
InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT MINIMALLY INVASIVE (MIS) LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) USING PRO245. AFTER CLIP PLACEMENT AND DEPLOYMENT, SURGEON MADE AN INCISION ON THE DISTAL TIP OF THE LEFT ATRIAL APPENDAGE (LAA) TIP TO DECOMPRESS LAA. PULSATILE BLOOD FLOW WAS NOTED AND DID NOT STOP. SURGEON PLACED A SECOND CLIP DISTAL TO THE FIRST CLIP, WHICH CONTROLLED BLEEDING. THERE WERE NO CONFIRMED DEVICE MALFUNCTIONS, AND THIS EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19206027 ↗
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® FLEX-Mini™ LAA Exclusion System ACHM40Atricure, 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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