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.
This recall has been terminated (originally issued March 14, 2014).
- Company
- Atricure Inc
- Recall Initiated
- January 23, 2014
- Posted
- March 14, 2014
- Terminated
- May 13, 2014
- Recall Number
- Z-1209-2014
- Quantity
- 46 units
- Firm Location
- Chester, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Distribution
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.
Lot / Code Info
Lot Number MFR-0424-1
Root Cause
Nonconforming Material/Component
Action Taken
On 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.