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.
This recall has been terminated (originally issued November 30, 2016).
- Company
- Atricure, Inc.
- Recall Initiated
- November 30, 2016
- Terminated
- February 15, 2018
- Recall Number
- Z-1148-2017
- Quantity
- 464 units
- Firm Location
- Mason, OH
- Official Source
- View on FDA website ↗
Reason for Recall
A complaint of the PRO2 jaw breaking prior to surgery being performed.
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.
Lot / Code Info
Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418
Root 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.