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AtriCure, Inc. recalls AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a convention
Recalled February 15, 2017 · FDA recall Z-1148-2017 · AtriCure
Hazard
A complaint of the PRO2 jaw breaking prior to surgery being performed. · FDA Class II
Units
464 units
Sold at
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.
Description
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.
Manufacturer(s)
AtriCure, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →