AtriClip® LAA Exclusion System PRO235Recalls & reported problems
Atricure, Inc. · AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35 · 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 10840143900174), received between Jul 28, 2022 and Jul 28, 2022 — 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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
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.
InjuryJul 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022 A PATIENT UNDERWENT A MINIMALLY INVASIVE EPICARDIAL SURGICAL LEFT VENTRICULAR LEAD PLACEMENT WITH CONCOMITANT LEFT ATRIAL APPENDAGE (LAA) EXCLUSION. THE PRO235 ATRICLIP WAS PLACED AND THE DISTAL TIP OF THE LEFT ATRIAL APPENDAGE (LAA) WAS EXCISED. AFTER EXCISION OF THE TIP OF THE LAA, PULSATILE BLEEDING WAS OBSERVED. A 45MM ENDO STAPLER WAS THEN USED TO CLOSE THE LAA. BLEEDING WAS STOPPED AND PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. THIS WAS A PROCEDURAL COMPLICATION AND THERE WAS NO REPORTED DEVICE MALFUNCTION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15122247 ↗
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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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