Recall Z-1148-2017
AtriCure, Inc. · initiated November 30, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418
Reason for recall
A complaint of the PRO2 jaw breaking prior to surgery being performed.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1148-2017
- Initiated
- November 30, 2016
- Terminated
- February 15, 2018
- Product code
- FZP – Clip, Implantable
- 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.
- Recalling firm
- AtriCure, Inc., Mason, OH