medical Class II Updated 2017-02-15

AtriCure, Inc. recalls AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgr

Recalled 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.

Hazard / Issue

A complaint of the PRO2 jaw breaking prior to surgery being performed.

Issued by

FDA

Affected 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

Lot/Code Info: Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418

View official government recall

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