Class II — AtriCure, Inc.
| Recalling firm | ATRICURE, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for a component failure of the device which could necessitate medical intervention. |
| Product | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. |
| Quantity | 298 |
| Distribution | Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland |
| Initiated | 2016-09-22 |
| Classified | 2016-11-09 |
| Terminated | 2018-02-15 |
| Recall number | Z-0377-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AtriCure, Inc. (Z-0377-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75178/
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