AtriClip PRO-Mini LAA Exclusion System PROM35Recalls & reported problems
Atricure, Inc. · LAA Exclusion System, PROM35 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10840143913563), received between Jan 8, 2026 and Jan 8, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.
MalfunctionJan 8, 2026
THE SURGEON ATTEMPTED TO DEPLOY AND IT DID NOT WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002864 ↗
Other Left Atrial Appendage Clip, Implantable devices
- Penditure™ LAAC45Medtronic, Inc. · Left atrial appendage clip, implantable7 reports
- Penditure™ LAAC50Medtronic, Inc. · Left atrial appendage clip, implantable1 death7 reports
- Penditure™ LAAC40Medtronic, Inc. · Left atrial appendage clip, implantable6 reports
- Penditure™ LAAC35Medtronic, Inc. · Left atrial appendage clip, implantable2 reports
- AtriClip PROV® LAA Exclusion System PROV50Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 death1 report
- AtriClip® FLEX-Mini™ LAA Exclusion System ACHM50Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 report
- AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion System PRO235Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 report
- AtriClip® FLEX-Mini™ LAA Exclusion System ACHM40Atricure, Inc. · Left Atrial Appendage Clip, Implantable1 report
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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