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 00818354015058), received between Aug 11, 2022 and Aug 11, 2022 — 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.
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.
InjuryAug 11, 2022Use of Device Problem; Use of Device Problem
ON (B)(6) 2022 A 65-YEAR-OLD MALE PATIENT UNDERWENT A STAND ALONE ROBOTIC LEFT ATRIAL APPENDAGE (LAA) EXCLUSION PROCEDURE. THE PRO245 CLIP WAS PLACED AND CLOSURE OF THE LAA WAS CONFIRMED. AS THE SURGEON WAS PULLING THE APPLICATOR BACK, BLEEDING WAS OBSERVED. THE PROCEDURE WAS CONVERTED TO A STERNOTOMY AND A PERFORATION WAS DISCOVERED OF A CARDIAC VEIN THAT WAS MEDIAL TO THE BASE OF THE LAA. THE PERFORATION WAS REPAIRED WITH A 4-0 PROLENE SUTURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Cardiac Perforation
MAUDE report 15209733 ↗
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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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