Atricure Inc: Medical Device Recall in 2014 - (Recall #: Z-1209-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.

Product Classification:

Class II

Date Initiated: January 23, 2014
Date Posted: March 26, 2014
Recall Number: Z-1209-2014
Event ID: 67572
Reason for Recall:

The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.

Status: Terminated
Product Quantity: 46 units
Code Information:

Lot Number MFR-0424-1

Distribution Pattern:

Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.

Voluntary or Mandated:

Voluntary: Firm initiated