AtriClip® PRO•V™ LAA Exclusion System PROV45 (REF A000973)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 00818354015140), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Misassembled” (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
- Misassembled1
Patient problems
- Cardiac Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2022Misassembled; Misassembled
ON (B)(6) 2022 DURING A LEFT ATRIAL APPENDAGE (LAA) EXCLUSION PROCEDURE, T WAS NOTICED THAT THE DACRON WAS NOT COMPLETELY COVERING THE PROV45 CLIP. AN INJURY TO THE LAA WAS OBSERVED. THE PATIENT WAS PLACED BACK ON-PUMP AND THE PROCEDURE WAS CONVERTED TO A STERNOTOMY TO REPAIR THE LAA. AN ATRICLIP PRO1 WAS PLACED ON THE THE LAA SUCCESSFULLY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Cardiac Perforation
MAUDE report 14717573 ↗
Other Clip, Implantable devices
- LIGAMAX EL5MLEthicon Endo-Surgery, LLC · CLIP, IMPLANTABLE3 deaths3,808 reports
- Endo Clip III 176630Covidien LP · CLIP, IMPLANTABLE1 death1,959 reports
- Epix® Universal Clip Applier CA500Applied Medical Resources Corporation · Clip, Implantable1 recall1 death1,183 reports
- Endo Clip II 176657Covidien LP · CLIP, IMPLANTABLE1,183 reports
- LIGACLIP ER320Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE1,115 reports
- Direct Drive® Clip Applier CA090Applied Medical Resources Corporation · Clip, Implantable1 death806 reports
- LAPRA-TY XC200Ethicon Inc. · CLIP, IMPLANTABLE791 reports
- Endo Clip 176625Covidien LP · CLIP, IMPLANTABLE1 death768 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page