Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A Recalled by AtriCure, Inc. Due to A complaint of the PRO2 jaw breaking prior...

Date: November 30, 2016
Company: AtriCure, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AtriCure, Inc. directly.

Affected Products

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.

Quantity: 464 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 31 states: AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MS, MO, NE, NY, NC, OH, OK, PA, SC, TN, TX, UT, VT, VA, WI

Affected (31 states)Not affected

About AtriCure, Inc.

AtriCure, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report