AtriClip™ LAA Exclusion System ACH135Recalls & reported problems
Atricure, Inc. · AtriClip® 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143900051), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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
- Tear, Rip or Hole in Device Packaging1
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.
MalfunctionDec 7, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
ON (B)(6) 2022 WHEN REMOVING AN ACH135 CLIP, A HOLE WAS NOTICED IN THE TYVEK. ANOTHER CLIP WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931576 ↗
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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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