AtriCure, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0377-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Product Classification:

Class II

Date Initiated: September 22, 2016

Date Posted: November 16, 2016

Recall Number: Z-0377-2017

Event ID: 75178

Reason for Recall:

There is a potential for a component failure of the device which could necessitate medical intervention.

Status: Terminated

Product Quantity: 298

Code Information:

Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773

Distribution Pattern:

Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI. Product was also shipped to the following countries: Poland and Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated