AtriClip® PRO•V™ LAA Exclusion System PROV45 (REF A000973-4)Recalls & reported problems
Atricure, Inc. · AtriClip® PRO•V™ 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 10840143901225), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- Low Cardiac Output1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2023Malposition of Device; Malposition of Device
A PATIENT UNDERWENT AN ON-PUMP, HEPARINIZED MINI MITRAL VALVE REPAIR WITH CONCOMITANT MAZE PROCEDURE AND LEFT ATRIAL APPENDAGE EXCLUSION. A PROV40 CLIP WAS PLACED SUCCESSFULLY. POST-OPERATIVE HEART CATHETERIZATION INDICATED THAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS OCCLUDED. PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE SURGEON PERFORMED A LEFT THORACOTOMY AND REMOVED THE PROV40 AND PLACED A BALLOON PUMP. HEART CATHETERIZATION THE NEXT DAY SHOWED THE LAD HAD NORMAL FLOW. THE PATIENT IS DOING WELL. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.
Patient problems: Low Cardiac Output
MAUDE report 16691483 ↗
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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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