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AtriClip™ LAA Exclusion System ACH245Recalls & reported problems

Atricure, Inc. · AtriClip® FLEX Gilinov-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 00818354014525), received between Jul 1, 2020 and Jul 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Slipped1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 1, 2020Device Slipped

    SURGEON EVALUATED ATRIAL APPENDAGE CLIP FOR USE DURING SURGERY. HE NOTICED THAT THE [INVALID] IN THE CLIP WERE TOO LOOSE AND REQUESTED ANOTHER ATRIAL APPENDAGE CLIP. THE SUBSTITUTE ATRIAL APPENDAGE CLIP WORKED APPROPRIATELY AND THERE WAS NO FURTHER INCIDENT. THERE WERE NO COMPLICATIONS NOTED DURING SURGERY AND THE PATIENT WAS ADMITTED TO THE ICU FOR POST OPERATIVE CARDIAC CARE. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10224101 ↗

Other Clip, Implantable devices

All Clip, Implantable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.