AtriClip® LAA Exclusion System PRO245 (REF A000967)Recalls & reported problems
Atricure, Inc. · AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45 · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143900198), received between Aug 5, 2024 and Aug 5, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2024
ELDERLY MALE WITH HISTORY OF ATRIAL FIBRILLATION. PROCEDURE: CONVERGENT MAZE AND LEFT ATRIAL APPENDAGE CLIP. DURING THE PROCEDURE, THE HANDLE ON THE DEVICE WOULD NOT RELEASE. ANOTHER DEVICE USED WITHOUT PROBLEM. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CLIP, IMPLANTABLE, ATRICLIP LAA EXCLUSION SYSTEM (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905096 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.