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 | A complaint of the PRO2 jaw breaking prior to surgery being performed. |
| Product | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek® lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box. |
| Quantity | 464 units |
| Distribution | Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI. Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom. |
| Initiated | 2016-11-30 |
| Classified | 2017-02-07 |
| Terminated | 2018-02-15 |
| Recall number | Z-1148-2017 |
| 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-1148-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76017/
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