Recall Z-1148-2017 ยท FZP Clip, Implantable
AtriCure, Inc.
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.
| Date | Nov 30, 2016 |
| Status | Terminated |
| Reason | A complaint of the PRO2 jaw breaking prior to surgery being performed. |
| Root cause | Component design/selection |
| Action | Recall notification letters were mailed to all Atricure customers. Email notification letters were forwarded to all Atricure field-based personnel, who may also conduct in-person meetings. Telephone calls will be made as needed and effectiveness checks will be conducted. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip AtriCure, Inc., Mar 18, 2016 |